Address correspondence to Robert Roger Lebel, MD Genetics Services, 360 West Butterfield Road, Suite 245, Elmhurst, IL 60126-5000; Ph: 708-832-4363; Fax 708-832-5980. All authors are members of the Great Lakes Regional Genetics Group, Subcommittee on Ethical and Legal Issues, Dr. Lebel is chair of the Subcommittee.

The demand for organs for therapeutic transplantation is great. Recent advances in medicine have made organ transplantation in newborns more feasible. However, there is a paucity of organs small enough for this age group.

It has been suggested that one source of organs to meet this demand might be anencephalic infants whose prognosis is believed to be hopeless because they survive usually for no more than a few days. Given restrictions of current law, in particular the Uniform Determination of Death Act (UDDA), the Uniform Anatomical Gift Act (UAGA), and similar laws, anencephalic infants cannot be used in this way until their brain stem activity ceases. Despite the provision of customary care, their solid organs usually undergo hypoxic injury during this process, making them unsuitable for transplant⁵. Thus, the availability of organs from anencephalic newborns for donation is limited, as function often falls below acceptable levels when the infants die with hypoxic injury to organs.

This has led to proposals which would make a special case of the anencephalic newborn by modifying the language and interpretation of existing laws defining death and regulating anatomical gifts. The aim of these proposals is to permit determinations of death to be made earlier in the process of dying, thereby making available more organs suitable for transplantation. They rest on the assumption that these infants are uniquely different from other handicapped newborns, and so can be used as organ sources without meeting the criteria for brain death (as articulated in UDDA).

One such proposal⁷ is founded on the fact that the anencephalic infant lacks integrative cerebral functions and faces imminent somatic demise; the conclusion is that such an infant cannot be considered alive. From this it follows that parents should be free to donate the organs of their anencephalic infants as soon as the fundamental malformation is diagnosed. The authors acknowledge that this would require amendment of the UDDA, which is currently in effect throughout the country. They seek to avoid the serious and complex issues of using organs prior to death as defined by the UDDA, by declaring that anencephalic infants are dead at an earlier stage in the dying process than are other persons, and therefore have no interest to outweigh those of potential organ recipients.

Such proposals raise complex ethical issues of subtlety and significance, without resolving them. We do not believe that the significant ethical issues here involved should be so skirted. Rather, we believe that before these important, complex and subtle problems can be addressed, several empirical matters must be resolved. We believe that there is insufficient persuasive evidence to support proposals to modify existing legislation. In fact, our reading of the literature suggests that they should be rejected on both scientific and practical grounds, as well as ethical ones^3-4.

·              First among the practical arguments is that the potential supply of organs from anencephalic newborns appears to have been overestimated. Many pregnancies affected by such lethal malformations are selectively terminated in the second trimester; many other affected infants are stillborn; some of those born alive have complex multiple-malformation syndromes in which the quality of transplantable organs is dubious.

·              Second, the number of patients that could benefit from transplantation of those organs seems to have been overestimated. The pool is limited by organ size appropriate for transplantation to an infant, and/or by the exigencies of tissue type matching.

·              Third, there is at present an uncomfortably high potential for error in distinguishing isolated anencephaly from chromosomal and inherited malformation syndromes that may present as anencephaly (e.g. the Meckel syndrome), and which may compromise the quality of potentially transplantable organs and tissues. The diagnosis is not always firmly established in time for appropriate decision-making; true anencephaly is sometimes confused with other conditions that are characterized by severe microcephaly, but may not be neonatally lethal.

·              Fourth, there is considerable scientific and medical uncertainty about the process of dying in anencephalics...or for that matter, in other humans.

From a strictly ethical foundation, the argument would pit considerations of beneficence toward infants eligible for organ transplantation against the rights of autonomy of potential donors. A small number of anencephalics might provide occasional organs to a few potential recipients. To achieve this would require our society to abandon a carefully honed set of regulations that have been based on long-contemplated cultural presuppositions and priorities.

Doing so would depend on a willingness to create a third category of humans: besides those living and those dead, there would also be those neither living nor dead but defined as non-persons available for harvesting of organs and tissues. The first subgroup in this category would be newborns affected by anencephaly. What other subgroups might be added, and based on what characteristics, remains to be imagined. Our imaginations balk at the consideration, especially when we allow ourselves to remember, as we must, the outcome of similar social experiments.

We believe that there has been no demonstration of a factual foundation to support the bypassing of important ethical and moral issues raised by any proposal to harvest organs from anencephalic infants prior to the completion of death as it is currently understood and defined (UDDA, UAGA). The case for undertaking these modifications has not been made adequately.

We conclude that proposals to modify existing laws that restrain such harvesting should be rejected, and we oppose them. We favor retaining, in their present form and application, the uniform laws defining death and regulating anatomical gifts. In other words, we do not believe that current concern over availability of suitable transplantable organs is sufficient to justify a revised or special-purpose definition of death. We consider this opinion to have broad support in the literature on death and dying^1,6. The prevalence of this perspective is illustrated by the recent refusal of a high court to permit artificial life support for harvesting of organs from an anencephalic infant².

Acknowledgment and disclaimer

This position paper was drafted as part of the general mandate of the Subcommittee: to address ethical and legal issues in clinical genetics. The topic has been discussed in a variety of fora, but few of the participants have approached it from a perspective of expertise in genetics (which brings with it some specialized knowledge of the biology of anencephaly). Thus, we chose to address the matter. The Steering Committee of the Great Lakes Regional Genetics Group elected not to adopt the position as official policy, but remanded the matter to the ethics committee of the Council of Regional Networks (CORN), which consists of the chairpersons of regional ethics committees nationwide. Members of that committee, in turn, were divided in opinions on the matter, and so the present authors determined to publish the paper as our personal perspective, in an effort to articulate one position and stimulate debate within the genetics community.

References

1. Capron A, Kass L (1972) A statutory definition of the standards for determing death: an appraisal and a proposal, Univ Penn Law Rev 87:106.

2. In re T.A.C.P., 609 So. 2D 588 (FLA. 1992).

3. Medearis DN, Holmes LB (1989) On the use of anencephalic infants as organ donors, New Engl J Med 321:391.

4. Medical Task Force on Anencephaly (1990) The infant with anencephaly, New Engl J Med 322:669.

5. Peabody JL, Emery JR, Ashwal S (1989) Experience with anencephalic infants as prospective organ donors, New Engl J Med 321:344.

6. President"s Commission (1981) Defining Death.

7. Trugg RD, Fletcher JC (1989) Anencephalic newborns: can organs be transplanted before brain death? New Engl J Med 321:388.