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Biotech / Medical : Biotransplant(BTRN)
BTRN 35.48+0.1%4:00 PM EST

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To: trevor john wilkinson who started this subject8/9/2000 8:45:58 PM
From: sim1  Read Replies (1) of 1475
 
Another transplant related editorial from the NEJM.

Organ Donation by Unrelated Donors

The New England Journal of Medicine -- August 10, 2000 -- Vol. 343, No. 6

Editorial

The transplantation of organs is a triumph of modern medicine. Life expectancy and the quality of life are greater with kidney transplantation than with maintenance dialysis. Successful liver and heart transplantations are lifesaving. However, the gap between the need for organs and their supply has widened progressively over the past decade. In 1999, 6448 people in the United States died while waiting for an organ transplant; 3088 of them were waiting for a kidney, and 1767 for a liver (United Network for Organ Sharing: unpublished data, May 6, 2000).

These grim facts have led to growing pressure to increase the supply of organs, both from cadaveric donors and from living donors. Some approaches to increasing the number of organs from cadaveric donors, such as improving programs designed to identify potential cadaveric donors and to solicit permission from family members to obtain organs, raise no ethical issues. Other approaches are ethically arguable, (1) such as application of the principle of "presumed consent," whereby persons are presumed to approve use of their organs after death unless they have expressly prohibited it. In Spain, Belgium, and Singapore, use of these approaches has substantially increased the number of cadaveric organs available for transplantation.

In many countries, including the United States, various strategies have been proposed to increase the supply of organs from living donors. The use of organs from living donors raises ethical questions, because the donors are subjected to surgery that is not performed to treat an illness and that has definite rates of mortality and morbidity. This practice is contrary to the medical precept "first, do no harm." Since the first kidney transplantation between identical twins was performed, both the medical profession and society at large have agreed that the use of organs from living donors is justified by the psychological benefit to the donor, who experiences the altruistic satisfaction of having assumed a risk in order to help another person.

Although early in the history of kidney transplantation in the United States a small number of transplants were from living donors who were not related to the recipients, by 1970 the use of unrelated donors had stopped. (2) At that time, the low success rate for the transplantation of organs from genetically unrelated donors did not justify the risk to the donors. As the success rate improved with the use of better immunosuppressive drugs, the use of organs from spouses and other "emotionally related" donors, such as close friends, became accepted practice. Some transplantation programs have recently begun to accept organs from donors with neither genetic nor emotional ties to the recipients. In this issue of the Journal, Matas and colleagues (3) describe their program for the transplantation of kidneys from donors who are not linked genetically or emotionally to the recipients ("nondirected donation") at the University of Minnesota, and Gridelli and Remuzzi (4) discuss the use of kidneys from unrelated donors in their review of various strategies for increasing the supply of organs.

The Minnesota program has been structured carefully to screen volunteer donors for both medical and psychological appropriateness. Some have questioned whether the motivation of persons who offer body parts to recipients with whom they have no familial or emotional ties can be entirely sound. However, we admire passersby who risk their lives to rescue strangers in dangerous situations, and the Nobel prize was recently awarded to Medecins sans Frontieres (Doctors without Borders), whose members offer medical care under hazardous conditions. Moreover, unrelated donors are not subject to the psychological pressure that family members may experience. Thus, there is little reason to doubt that normal persons who offer their organs for transplantation may have the highest altruistic motives for doing so. However, the rate of death from nephrectomy is approximately 0.03 percent, and the rate of morbidity (beyond perioperative pain) ranges from 1 to 10 percent. In other words, if 10,000 unrelated kidney donors were recruited each year, 3 might die, and as many as 1000 might have various complications.

The issue of the benefit versus the risk of obtaining organs from unrelated living donors is even more troubling in the case of organs other than the kidney, such as the liver. The mortality rate associated with partial hepatectomy, which has been performed many times in related donors (often in the case of a donation from parent to child), is uncertain but probably in the range of 0.2 percent, and the rate of morbidity is about 10 percent. (4,5) However, a liver transplant is potentially lifesaving, whereas a kidney transplant may extend life or improve its quality but it does not save the life of a patient on dialysis. How can we balance the potential for a greater benefit to one person against the greater risk to another? Is there a point at which the risk of the procedure is so great that we should not subject volunteers to it, not even those with the most unequivocally altruistic motives?

These questions underscore the critical importance of refraining from any attempt to induce or solicit persons to serve as unrelated donors. The Minnesota program for nondirected kidney donation includes safeguards against such attempts. However, unrelated donors (as well as related donors) are eligible for financial aid from the institution. Payment for organs is illegal in the United States because it is generally considered to be an unethical inducement to donate organs, although this opinion is disputed by prominent physicians and ethicists. (6) The financial aid offered at the University of Minnesota is presumably small and is intended only to defray expenses. A similar payment by the state has been proposed to increase organ donation in Pennsylvania. (7) The plan would offer $300 to organ donors and their families, which could be used only for expenses such as food, housing, and transportation. Small payments for expenses are unlikely to induce unrelated persons to donate organs. The danger is that as the number of programs for such donations increases, institutions may be tempted to compete financially for donors.

Any plan to offer kidneys from unrelated donors only to patients on the waiting list at the institution that recruits the donors also raises the possibility of conflicts of interest. Programs for nondirected donation will be publicized, if not by the institutions that establish them then by the media. The institutions may benefit from favorable publicity about their transplantation programs in general, and especially about their ability to offer their patients a chance to bypass the often long wait for a cadaveric kidney. There is already competition among transplantation programs for unrelated living donors. In an advertisement in the New York Times, (8) for example, the University of Maryland described its program as "the world's largest, most successful live donor laparoscopic kidney transplant program" and stated, "Donating a kidney is a tough decision. Deciding where to go is easy." Competition for unrelated living donors could lead to unethical and potentially dangerous practices, such as using less stringent criteria for the selection of donors, failing to keep medical teams caring for donors completely separate from the teams caring for recipients, and offering donors larger payments for "expenses."

In a recent survey, one in four Americans said that they would consider donating a kidney or part of another organ to a stranger. (9) I doubt that a substantial number of volunteers will in fact be available if strict criteria for selection, including the requirement that altruism be the sole motive for donation, are applied, but I fear that the criteria will be relaxed to expand the pool of donors. To guard against this possibility, potential donors should be evaluated at an institution other than the one where the organs will be transplanted. The organs should be distributed regionally under rules set by the United Network for Organ Sharing, as is the case for cadaveric organs. If such arrangements greatly decrease the supply of organs, so be it. We must avoid a slippery slope on which the benefits to the transplant recipients and to the institutions that care for them come to outweigh the risks to the donors.

Norman G. Levinsky, M.D.
Boston University Medical Center
Boston, MA 02118
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