DECLARING DEATH AND TRANSPLANTING ORGANS – RECENT DEVELOPMENTS AND CONTINUING CONTROVERSIES
By Ben A. Rich, J.D., Ph.D., UC Davis School of Medicine Bioethics Endowed Professor
Two recent developments have highlighted the continuing controversy over policies and protocols for declaring death in patients who have been identified as organ donors. In July 2008, a San Luis Obispo County, Calif., prosecutor charged a San Francisco transplant surgeon with three felonies arising out of his participation in efforts to retrieve organs from a 26-year-old disabled man hospitalized at a medical center in that locality. This appears to be the first time criminal charges have been filed against a physician involved in a transplant protocol. The thrust of the criminal complaint is that the surgeon became involved in the organ donor's case before death had been declared and that he ordered excessive sedatives with the intent of accelerating the patient's death in order to retrieve the organs more expeditiously. The defendant surgeon denies all charges that his conduct was criminal, or even inappropriate. Interestingly, despite this alleged wrongful conduct, the patient's organs never were recovered because the patient did not die within the timeframe required to insure their viability.
The second development was the publication of a report in the New England Journal of Medicine (August, 2008) concerning three cases in Denver, Colo., which constituted the unprecedented transplantation in children of hearts from donors who died from cardiocirculatory causes. The authors of the report characterized the cases as an "institutional clinical trial." Appearing with the report were three bioethical commentaries suggesting that there is still much confusion and controversy about these so-called "nonheartbeating organ donor protocols."
Defining, declaring human death
Recovery of solid organs for transplantation usually follows a declaration of brain death, which is characterized as total and irreversible cessation of all brain function including the brain stem. When first proposed in 1968 by an Ad Hoc Committee of the Harvard Medical School, this new formulation of death was noted for its potential to greatly expand the number of viable organs available for transplant. The concept of brain death was quickly adopted throughout the United States with remarkably little controversy. Nevertheless, use of the term brain death by clinicians and lay persons in the decades since has continued to evidence a significant lack of conceptual clarity. It is not at all uncommon to encounter case descriptions such as the following: Mr. Jones was declared brain dead at 10:15 p.m. on Thursday. Thereafter, all life-support was withdrawn. At 12:05 a.m. on Friday the patient died.
Such accounts suggest that we do not really believe that patients who meet brain-death criteria are dead.
An accurate determination of death is essential in order to fulfill what has come to be characterized in the transplant community as the "dead-donor rule," signifying that the prospective organ donor must be determined to be dead to a reasonable degree of medical certainty by acceptable clinical measures before organs can be recovered.
While use of the brain-death protocol has certainly expanded the number of viable organs available for transplant, thousands of patients die each year while on waiting lists because the demand continues to far exceed the supply. One among many efforts to address this chronic undersupply has been the development of protocols for organ donation after circulatory (or cardiac) death.
Donation after circulatory death protocols
Originally characterized as "nonheartbeating organ donor protocols," such patients are gravely and irreversibly ill, comatose or unconscious, and usually receiving one or more forms of life-support, but do not meet brain death criteria. The decision to discontinue life support is one made either by the patient (when still capable of making decisions) or by the patient's surrogate and is made prior to and independent of any discussion about organ donation. The key criterion for determining death by cardiopulmonary criteria is that heartbeat and respiration have irreversibly ceased. The "irreversible" component is a major concern because a conclusion of irreversibility may be based upon one or more of three options: 1) cardiopulmonary function will not resume spontaneously; 2) cannot be made to resume through resuscitation measures; or 3) resuscitation will not be attempted for morally acceptable reasons. When the Institute of Medicine examined these protocols originally in 1997, it approved determination of cardiopulmonary death based on a combination of options 1 and 3. A decision not to attempt resuscitation leaves open a concern about reversibility since cardiopulmonary resuscitation is erroneously perceived by the general public to be much more efficacious than the clinical data would support.
Another concern has been how long it is necessary or appropriate to wait after the cessation of cardiopulmonary function for a possible spontaneous resumption prior to determination of death in order to comply with the "dead-donor rule" Some early protocols suggested waiting as long as five minutes but more recent versions have been as short as 75 seconds. The longer the period seeks to bolster the validity of the "irreversibility" claim, while the shorter period prioritizes the viability of the organ(s) to be transplanted. In the three pediatric organ retrieval cases from Denver, three minutes passed from cardiopulmonary cessation to declaration of death in the first case but only 75 seconds in the second and third based upon data suggesting that the longest period before autoresuscitation of any patient (child or adult) was 60 seconds.
Continuing ethical debate
The fact that the organ transplants in the Denver pediatric cases involved hearts rather than other solid organs vividly highlights the controversy surrounding the deaddonor rule. How can the organ donor be legitimately declared dead if, shortly thereafter, their heart will be transplanted into another patient and successfully restarted? Two of the three commentaries propose alternative solutions to this moral quandary. One suggests abandoning the dead-donor rule in favor of allowing recovery of vital organs with prior patient or proxy consent if the patient has devastating and irreversible neurologic injuries but some continuing brain function. The other suggests abandoning the whole brain-death formulation of current law in favor of a higher brain-death formulation based upon total loss of those brain functions that support consciousness. Both suggestions are themselves controversial, insuring that ongoing efforts to expand the supply of viable organs for transplant will inevitably carry profound ethical implications.