The (not so) Dead Donor Rule Revisited

Wow, I have been away for awhile!

I received an article on organ donation today, that was published in August, 2008 in the New England Journal of Medicine. I am not an advocate of organ donation, and I have come under fire in previous posts from those who are. You can click on this link to read it, or just read what I copied below.


Organ Donation after Cardiac Death

In this issue of the Journal, Boucek et al. (pages 709–714) report on three cases of heart transplantation from infants who were pronounced dead on the basis of cardiac criteria. The three Perspective articles and a video roundtable discussion at www.nejm.org address key ethical aspects of organ donation after cardiac death. Bernat and Veatch comment on the cases described by Boucek et al.; Truog and Miller raise a fundamental question about the dead donor rule. In a related Perspective roundtable, moderator Atul Gawande, of Harvard Medical School, is joined by George Annas, of the Boston University School of Public Health; Arthur Caplan, of the University of Pennsylvania; and Robert Truog. Watch the roundtable online at www.nejm.org.

Since its inception, organ transplantation has been guided by the overarching ethical requirement known as the dead donor rule, which simply states that patients must be declared dead before the removal of any vital organs for transplantation. Before the development of modern critical care, the diagnosis of death was relatively straightforward: patients were dead when they were cold, blue, and stiff. Unfortunately, organs from these traditional cadavers cannot be used for transplantation. Forty years ago, an ad hoc committee at Harvard Medical School, chaired by Henry Beecher, suggested revising the definition of death in a way that would make some patients with devastating neurologic injury suitable for organ transplantation under the dead donor rule.1

The concept of brain death has served us well and has been the ethical and legal justification for thousands of lifesaving donations and transplantations. Even so, there have been persistent questions about whether patients with massive brain injury, apnea, and loss of brain-stem reflexes are really dead. After all, when the injury is entirely intracranial, these patients look very much alive: they are warm and pink; they digest and metabolize food, excrete waste, undergo sexual maturation, and can even reproduce. To a casual observer, they look just like patients who are receiving long-term artificial ventilation and are asleep.

The arguments about why these patients should be considered dead have never been fully convincing. The definition of brain death requires the complete absence of all functions of the entire brain, yet many of these patients retain essential neurologic function, such as the regulated secretion of hypothalamic hormones.2 Some have argued that these patients are dead because they are permanently unconscious (which is true), but if this is the justification, then patients in a permanent vegetative state, who breathe spontaneously, should also be diagnosed as dead, a characterization that most regard as implausible. Others have claimed that “brain-dead” patients are dead because their brain damage has led to the “permanent cessation of functioning of the organism as a whole.”3 Yet evidence shows that if these patients are supported beyond the acute phase of their illness (which is rarely done), they can survive for many years.4 The uncomfortable conclusion to be drawn from this literature is that although it may be perfectly ethical to remove vital organs for transplantation from patients who satisfy the diagnostic criteria of brain death, the reason it is ethical cannot be that we are convinced they are really dead.

Over the past few years, our reliance on the dead donor rule has again been challenged, this time by the emergence of donation after cardiac death as a pathway for organ donation. Under protocols for this type of donation, patients who are not brain-dead but who are undergoing an orchestrated withdrawal of life support are monitored for the onset of cardiac arrest. In typical protocols, patients are pronounced dead 2 to 5 minutes after the onset of asystole (on the basis of cardiac criteria), and their organs are expeditiously removed for transplantation. Although everyone agrees that many patients could be resuscitated after an interval of 2 to 5 minutes, advocates of this approach to donation say that these patients can be regarded as dead because a decision has been made not to attempt resuscitation.

This understanding of death is problematic at several levels. The cardiac definition of death requires the irreversible cessation of cardiac function. Whereas the common understanding of “irreversible” is “impossible to reverse,” in this context irreversibility is interpreted as the result of a choice not to reverse. This interpretation creates the paradox that the hearts of patients who have been declared dead on the basis of the irreversible loss of cardiac function have in fact been transplanted and have successfully functioned in the chest of another. Again, although it may be ethical to remove vital organs from these patients, we believe that the reason it is ethical cannot convincingly be that the donors are dead.

At the dawn of organ transplantation, the dead donor rule was accepted as an ethical premise that did not require reflection or justification, presumably because it appeared to be necessary as a safeguard against the unethical removal of vital organs from vulnerable patients. In retrospect, however, it appears that reliance on the dead donor rule has greater potential to undermine trust in the transplantation enterprise than to preserve it. At worst, this ongoing reliance suggests that the medical profession has been gerrymandering the definition of death to carefully conform with conditions that are most favorable for transplantation. At best, the rule has provided misleading ethical cover that cannot withstand careful scrutiny. A better approach to procuring vital organs while protecting vulnerable patients against abuse would be to emphasize the importance of obtaining valid informed consent for organ donation from patients or surrogates before the withdrawal of life-sustaining treatment in situations of devastating and irreversible neurologic injury.5

What has been the cost of our continued dependence on the dead donor rule? In addition to fostering conceptual confusion about the ethical requirements of organ donation, it has compromised the goals of transplantation for donors and recipients alike. By requiring organ donors to meet flawed definitions of death before organ procurement, we deny patients and their families the opportunity to donate organs if the patients have devastating, irreversible neurologic injuries that do not meet the technical requirements of brain death. In the case of donation after cardiac death, the ischemia time inherent in the donation process necessarily diminishes the value of the transplants by reducing both the quantity and the quality of the organs that can be procured.

Many will object that transplantation surgeons cannot legally or ethically remove vital organs from patients before death, since doing so will cause their death. However, if the critiques of the current methods of diagnosing death are correct, then such actions are already taking place on a routine basis. Moreover, in modern intensive care units, ethically justified decisions and actions of physicians are already the proximate cause of death for many patients — for instance, when mechanical ventilation is withdrawn. Whether death occurs as the result of ventilator withdrawal or organ procurement, the ethically relevant precondition is valid consent by the patient or surrogate. With such consent, there is no harm or wrong done in retrieving vital organs before death, provided that anesthesia is administered. With proper safeguards, no patient will die from vital organ donation who would not otherwise die as a result of the withdrawal of life support. Finally, surveys suggest that issues related to respect for valid consent and the degree of neurologic injury may be more important to the public than concerns about whether the patient is already dead at the time the organs are removed.

In sum, as an ethical requirement for organ donation, the dead donor rule has required unnecessary and unsupportable revisions of the definition of death. Characterizing the ethical requirements of organ donation in terms of valid informed consent under the limited conditions of devastating neurologic injury is ethically sound, optimally respects the desires of those who wish to donate organs, and has the potential to maximize the number and quality of organs available to those in need.

The opinions expressed in this article are those of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services.

No potential conflict of interest relevant to this article was reported.

Source Information
Dr. Truog is a professor of medical ethics and anesthesia (pediatrics) in the Departments of Anesthesia and Social Medicine at Harvard Medical School and the Division of Critical Care Medicine at Children's Hospital Boston — both in Boston. Dr. Miller is a faculty member in the Department of Bioethics, National Institutes of Health, Bethesda, MD

Organ Donation; the Unethical Harvest

Is the industry of harvesting organs about to undergo an ethical and moral face lift? The New England Journal of Medicine reports in a very convincing article that the new definitions of cardiac and brain death may actually not be that convincing after all: (emphasis mine)

Since its inception, organ transplantation has been guided by the overarching ethical requirement known as the dead donor rule, which simply states that patients must be declared dead before the removal of any vital organs for transplantation. Before the development of modern critical care, the diagnosis of death was relatively straightforward: patients were dead when they were cold, blue, and stiff. Unfortunately, organs from these traditional cadavers cannot be used for transplantation. Forty years ago, an ad hoc committee at Harvard Medical School, chaired by Henry Beecher, suggested revising the definition of death in a way that would make some patients with devastating neurologic injury suitable for organ transplantation under the dead donor rule.¹

The concept of brain death has served us well and has been the ethical and legal justification for thousands of lifesaving donations and transplantations. Even so, there have been persistent questions about whether patients with massive brain injury, apnea, and loss of brain-stem reflexes are really dead. After all, when the injury is entirely intracranial, these patients look very much alive: they are warm and pink; they digest and metabolize food, excrete waste, undergo sexual maturation, and can even reproduce. To a casual observer, they look just like patients who are receiving long-term artificial ventilation and are asleep.

The arguments about why these patients should be considered dead have never been fully convincing. The definition of brain death requires the complete absence of all functions of the entire brain, yet many of these patients retain essential neurologic function, such as the regulated secretion of hypothalamic hormones.² Some have argued that these patients are dead because they are permanently unconscious (which is true), but if this is the justification, then patients in a permanent vegetative state, who breathe spontaneously, should also be diagnosed as dead, a characterization that most regard as implausible. Others have claimed that "brain-dead" patients are dead because their brain damage has led to the "permanent cessation of functioning of the organism as a whole."³ Yet evidence shows that if these patients are supported beyond the acute phase of their illness (which is rarely done), they can survive for many years.⁴ The uncomfortable conclusion to be drawn from this literature is that although it may be perfectly ethical to remove vital organs for transplantation from patients who satisfy the diagnostic criteria of brain death, the reason it is ethical cannot be that we are convinced they are really dead.

Over the past few years, our reliance on the dead donor rule has again been challenged, this time by the emergence of donation after cardiac death as a pathway for organ donation. Under protocols for this type of donation, patients who are not brain-dead but who are undergoing an orchestrated withdrawal of life support are monitored for the onset of cardiac arrest. In typical protocols, patients are pronounced dead 2 to 5 minutes after the onset of asystole (on the basis of cardiac criteria), and their organs are expeditiously removed for transplantation. Although everyone agrees that many patients could be resuscitated after an interval of 2 to 5 minutes, advocates of this approach to donation say that these patients can be regarded as dead because a decision has been made not to attempt resuscitation.

This understanding of death is problematic at several levels. The cardiac definition of death requires the irreversible cessation of cardiac function. Whereas the common understanding of "irreversible" is "impossible to reverse," in this context irreversibility is interpreted as the result of a choice not to reverse. This interpretation creates the paradox that the hearts of patients who have been declared dead on the basis of the irreversible loss of cardiac function have in fact been transplanted and have successfully functioned in the chest of another. Again, although it may be ethical to remove vital organs from these patients, we believe that the reason it is ethical cannot convincingly be that the donors are dead.

At the dawn of organ transplantation, the dead donor rule was accepted as an ethical premise that did not require reflection or justification, presumably because it appeared to be necessary as a safeguard against the unethical removal of vital organs from vulnerable patients. In retrospect, however, it appears that reliance on the dead donor rule has greater potential to undermine trust in the transplantation enterprise than to preserve it. At worst, this ongoing reliance suggests that the medical profession has been gerrymandering the definition of death to carefully conform with conditions that are most favorable for transplantation. At best, the rule has provided misleading ethical cover that cannot withstand careful scrutiny. A better approach to procuring vital organs while protecting vulnerable patients against abuse would be to emphasize the importance of obtaining valid informed consent for organ donation from patients or surrogates before the withdrawal of life-sustaining treatment in situations of devastating and irreversible neurologic injury.⁵

What has been the cost of our continued dependence on the dead donor rule? In addition to fostering conceptual confusion about the ethical requirements of organ donation, it has compromised the goals of transplantation for donors and recipients alike. By requiring organ donors to meet flawed definitions of death before organ procurement, we deny patients and their families the opportunity to donate organs if the patients have devastating, irreversible neurologic injuries that do not meet the technical requirements of brain death. In the case of donation after cardiac death, the ischemia time inherent in the donation process necessarily diminishes the value of the transplants by reducing both the quantity and the quality of the organs that can be procured.

Many will object that transplantation surgeons cannot legally or ethically remove vital organs from patients before death, since doing so will cause their death. However, if the critiques of the current methods of diagnosing death are correct, then such actions are already taking place on a routine basis. Moreover, in modern intensive care units, ethically justified decisions and actions of physicians are already the proximate cause of death for many patients — for instance, when mechanical ventilation is withdrawn. Whether death occurs as the result of ventilator withdrawal or organ procurement, the ethically relevant precondition is valid consent by the patient or surrogate. With such consent, there is no harm or wrong done in retrieving vital organs before death, provided that anesthesia is administered. With proper safeguards, no patient will die from vital organ donation who would not otherwise die as a result of the withdrawal of life support. Finally, surveys suggest that issues related to respect for valid consent and the degree of neurologic injury may be more important to the public than concerns about whether the patient is already dead at the time the organs are removed.

In sum, as an ethical requirement for organ donation, the dead donor rule has required unnecessary and unsupportable revisions of the definition of death. Characterizing the ethical requirements of organ donation in terms of valid informed consent under the limited conditions of devastating neurologic injury is ethically sound, optimally respects the desires of those who wish to donate organs, and has the potential to maximize the number and quality of organs available to those in need.

Interesting article, isn't it? Did you catch the part about administering anesthetics to the organ donor? That's because it really hurts when an organ procurement team cuts out your heart or lungs! Some Catholics will say that Pope John Paul has approved of organ donation, but he stressed that organ donation must be performed in an ethically accepted manner: (emphasis mine)

"vital organs which occur singly in the body can be removed only after death, that is from the body of someone who is certainly dead. This requirement is self-evident, since to act otherwise would mean intentionally to cause the death of the donor in disposing of his organs. This gives rise to one of the most debated issues in contemporary bioethics, as well as to serious concerns in the minds of ordinary people. I refer to the problem of ascertaining the fact of death. When can a person be considered dead with complete certainty? In this regard, it is helpful to recall that the death of the person is a single event, consisting in the total disintegration of that unitary and integrated whole that is the personal self. It results from the separation of the life-principle (or soul) from the corporal reality of the person. The death of the person, understood in this primary sense, is an event which no scientific technique or empirical method can identify "

Which leads me back to the question I have never been able to resolve, and the reason I am not an organ donor - When does the soul leave the body? When the doctor pronounces brain or cardiac death while at the same time looking for an organ donor card, or when the traditional definition of biological death occurs; that is, when the patient is cold, blue and stiff.

Organ donation can kill you

It's what I've been saying all along:

Vital organ donation
What you don't know can kill you!

August 8, 2007
Paul A. Byrne, M.D.

You've probably seen TV commercials, billboards, and magazine articles encouraging you to give the "gift of life" through vital organ donation. It saves lives. It gives meaning to a wasteful, tragic death. But before you fill out an organ donor card, here are a few things to think about.

Vital organs (from the Latin vitae, meaning life) are those organs like the heart, liver, lungs, and pancreas that are necessary for life. In order to be suitable for transplant, they need to be removed from the donor before respiration and circulation cease. Otherwise, these organs are not suitable, since damage occurs within a brief time after circulation of blood with oxygen stops. Removing vital organs from a living person prior to cessation of circulation and respiration will cause the donor's death.

Portions of some vital organs can be removed without causing death of the donor — for example, one of two kidneys, a lobe of a liver, a lobe of a lung. But other vital organs, like the heart, cannot be removed without killing the donor.

Since vital organs are not useful once the person is dead, and since taking them causes death, how is vital organ donation possible?

That's where "brain death" comes in.

Before 1968, a person was dead only when his or her breathing and heart stopped. In the 1950s and 60s, when surgeons developed the ability to transplant vital organs, the medical community faced a legal and ethical dilemma: vital organs must be taken from a living body, but removing vital organs will cause death.

In 1968, a committee at Harvard Medical School formulated an alternate definition of death: "brain death." They decided that when certain criteria are fulfilled (for example no response, coma, and need for a ventilator to support breathing), the patient can be declared "brain dead." Even when the heart is pumping and the lungs are oxygenating blood, the committee decided that vital organs could be removed without legal or ethical consequences.

In 1980, the Uniform Determination of Death Act, or UDDA, was approved by Congress. According to the UDDA, death may be declared when a person has sustained either "irreversible cessation of circulatory and respiratory functions" or "irreversible cessation of all functions of the entire brain, including the brain stem." Since then, all 50 states consider cessation of brain functioning as death.

Moreover, between 1968 and 1978, more than thirty different sets of criteria for "brain death" were adopted in the United States and elsewhere. Thus, if a hospital has a potential donor, the doctors at the hospital can choose which criteria for determining brain death will best suit its current need.

Dead or "Brain Dead?" What's the Difference?

If you were to compare a dead body with someone declared "brain dead," you would find that the dead body is pale, cold, stiff, and unresponsive. There is no heartbeat, no body functions, no breathing, and no movement. Someone declared "brain dead" is warm and flexible. There is a beating heart, normal color, temperature, and blood pressure. Most functions continue, including digestion, excretion, and maintenance of fluid balance with normal urine output. There will often be response to surgical incisions. In a long enough period of observation, someone declared "brain dead" will show healing and growth, and will go through puberty if they are a child.

There have been numerous instances of young pregnant women with head injuries declared "brain dead," yet with careful medical management they are able to carry the child to birth. In the longest recorded instance, the child was carried for 107 days.

In other cases, during the excision of vital organs, doctors find they need to use anesthesia and other drugs to control muscle spasms, blood pressure and heart rate changes, and other bodily protective mechanisms common in living patients.

Hospitals allow "brain-dead" patients to occupy a bed; insurance companies cover expenses as they do for other living patients. If the patients' organs are suitable for transplantation, any transfer of the patients to another hospital is covered by insurance. If they are used for teaching purposes or vital organ donation, they (the "brain-dead" patients) receive life support procedures, blood transfusions, antibiotics and other medications, or anything else necessary to maintain their organs in a healthy state. Insurance also covers all this.

Interestingly, in cases of suspected homicide, attorneys hesitate to file charges until the patient is truly dead, even if the patient has been declared "brain dead." But in the meantime, if someone else would act to "finish the job," this "new aggressor" could possibly be held or prosecuted for murder, since the patient is alive, but legally "brain dead." Other discussions with legal experts suggest that since the victim is legally dead, the case for murder by the second assailant would not be tenable since the victim is already legally dead. However, the second assailant could be liable for intent to mutilate the "corpse," which in some jurisdictions is the property of the victim's family.

Legally "Brain-dead" patients are considered corpses or cadavers, and are called such by organ retrieval networks. The corpses can be used for teaching, for trying out new procedures, and for vital organ harvesting. Yet these same "corpses" are carrying unborn children to successful delivery. Certainly this is extraordinary behavior by a "cadaver!"

It appears that "dead" is not the same as "brain dead." So if "brain dead" persons aren't dead, what are they?

More Moral Dilemmas Created By The Existing Flawed Definition Of Death

Sometimes a potential organ donor does not meet the criteria for "brain death," but has sustained certain injuries or has an illness suggesting that death will occur soon. Such cases brought about the development of "non heart-beating donation" (NHBD), more recently labeled donation by cardiac death (DCD) — in which treatments considered extraordinary means, such as mechanical ventilation, are discontinued and certain drugs are used to lower the blood pressure and cause the patient to be pulseless. As soon as circulation stops, death is declared, and after a few minutes, which vary in different institutions, the body could still be resuscitated to restore cardiac and respiratory activity. This cannot be accomplished in the remains of someone who is truly dead.

It seems clear that in certain cases, we are playing games with human lives for utilitarian gain. So glaring is the reality of this issue that there are those who now argue that doctors should not be burdened with determination of death criteria, since the good of organ donation outweighs the harm (killing) done to the donor. Scary, isn't it?

Government Involvement

The federal government is deeply involved in transplant programs for reasons that are unclear. A federal mandate issued in 1998 states that physicians, nurses, pastors, and other health care workers may not speak to a family of a potential organ donor without first obtaining approval from the regional organ retrieval system. If there is the possibility of vital organs available for transplant, a trained "designated requester" visits with the family first, even if the family adamantly opposes organ donation. If someone at the hospital speaks to the family first, the hospital risks losing its accreditation and possibly federal funding.

Why the "designated requester"? Studies show that these people have greater success obtaining permission for organ donation. They're trained to sell the concept, using emotionally-laden phrases such as "gift of life," "your loved one's heart will live on in someone else," and other similar platitudes, all empty of true meaning.

Where Does the Money Go?

The donation and transplant industry costs billions of dollars a year, according to several sources (including a 1996 series by Forbes Magazine). But it's difficult to obtain financial data. One thing is clear: donor families do not receive any monetary benefit from their "gift of life."

Something to Think About

Based on what you've just read, take a moment to ponder the following:

• Why can health insurance cover intensive care costs on "brain dead" patients?
  
  
• Why do "brain dead" patients often receive intravenous fluids, antibiotics, ventilator care, and other life support measures?
  
  
• Why is it wrong to tell families their "brain-dead" loved one is dead?
  
  
• Why do "brain-dead" organ donors often receive anesthesia and other drugs to stop natural physical responses when they're undergoing vital organ harvesting?
  
  
• How can "brain dead" patients have normal body functions, including vital signs, if they're dead?
  
  
• How can a "brain-dead" pregnant mother deliver a normal, healthy infant?
  
  
• Why does a ventilator work on someone declared a "brain-dead" person, but not on a corpse?
  
  
• Why is it wrong to carry out burial or cremation of a "brain-dead" person?
  
  
• Are "brain-dead" persons truly dead?
  
  
• Are they alive?
  
  

But it is not up to us to decide who has the right to live . . . and who must die!

---

Dr. Paul A. Byrne, a Neonatologist, is Director of Neonatology and Director of Pediatrics at St. Charles Mercy Hospital in Oregon, Ohio, is Clinical Professor of Pediatrics University of Toledo College of Medicine, Board Certified in Pediatrics and Neonatal-Perinatal Medicine, Member of Fellowship of Catholic Scholars.

Dr. Byrne is past-President of the Catholic Medical Association (USA), formerly Clinical Professor of Pediatrics at Creighton University School of Medicine in Omaha, NE, and at St. Louis University School of Medicine in St. Louis, MO. He is author and producer of the film "Continuum of Life" and author of the books "Life, Life Support and Death," "Beyond Brain Death," and "Brain Death Is Not Death."

Dr. Byrne has presented testimony on "life issues" to eight state legislatures beginning in 1967. He opposed Dr. Kevorkian on the television program "Cross-Fire." He has been interviewed on Good Morning America, public television in Japan and participated in the British Broadcasting Corporation Documentary "Are the Donors Really Dead?" Dr. Byrne has authored articles against euthanasia, abortion, and "brain death" in medical journals, law literature and lay press.

Paul was married to Shirley for forty-eight years until she entered her eternal reward on Christmas 2005. They are the proud parents of twelve children and grandparents of twenty-six grandchildren.

The dilemma of organ donation

Edit -August 31, 2008 - before you sign an organ donor card, please also see these more recent posts on the dilemma of organ donation.

A young handicapped man with little ability to pay for medical expenses is murdered for his organs by a doctor who kept administering lethal doses of morphine and Ativan. Sound far fetched? It happened in California, and the doctor who administered the lethal dose of drugs was actually working for a California organ-harvesting corporation. When the twenty six year old didn't die from the overdoses, he was left without life support until he died nine hours later.

The push for social acceptance of euthanasia and a high demand for organs creates situations where the donor is no longer viewed and cared for as a patient, but seen as the means to supply life to the patient waiting for organs. With no universally-accepted medical definition of brain-death, the door is wide open for abuse of organ donation. In China, prisoners are killed for their organs after a match is found, and in Canada and the US, "non-beating heart" organ donations have the ethical implication of doctors decreasing the wait time after cardiac asystole in order to harvest "better" organs.

The Catholic Church considers organ donation an act of charity and love. Pope John Paul II calls organ donation an act of everyday heroism in the 1995 encyclical Evangelium Vitae:
"A particularly praiseworthy example of such gestures is the donation of organs, performed in an ethically acceptable manner, with a view to offering a chance of health and even life itself to the sick who sometimes have no hope." (Evangelium Vitae, n. 86).

The Ethical and Religious Directives for Catholic Health Care Services states that “Catholic health care institutions should encourage and provide the means whereby those who wish to do so may arrange for the donation of their organs and bodily tissue, for ethically legitimate purposes, so that they may be used for donation and research after death.” Directive No. 64: “Such organs should not be removed until it has been medically determined that the patient has died. (my emphasis). In order to prevent any conflict of interest, the physician who determines death should not be a member of the transplant team.”

It used to be fairly easy to determine when death had occurred. Now, with the high demand for organ donation and the relatively low supply of donors, calling a death has become an ethical issue when the patient is also an organ donor. Patients who are organ donors are kept alive until the removal of their vital organs causes their death.

Removing life support before death has occurred for the sake of harvesting higher quaility organs is a moral dilemma that keeps me from being an organ donor. That, and the very real moral question of when exactly does the soul leave the body? The Catholic Church has always held that the soul leaves the body at the moment of biological death, and with organ donation, biological death occurs when the transplant team removes the vital organs.