As therapy for end-stage disease, organ transplantation remains the standard, prolonging life and improving functional status. However, as the number of people waiting to receive transplants continues to grow, the number of donors does not. In the year 2001, one of four patients on the waiting list for solid organ transplants died waiting. Currently, the number of eligible recipients is increasing 11% per year, whereas cadaveric transplants are increasing at only 1.6% per year, indicating this ratio will worsen (1).
Several strategies have been used to address the shortage (2). For liver and kidney disease, living-related transplants benefit many, as does splitting liver grafts between multiple recipients. Although nearly half of all kidney transplants are from living donors, only 10% of liver transplants are performed in this fashion (1). Another approach has been the development of artificial organs, most notably the use of left ventricular assist devices for end-stage heart disease. These devices constitute the standard of care as a “bridge” to transplant for those listed who are unlikely to receive an organ in time. However, although this helps those patients who receive such a device, it serves to worsen the proportion of patients who are waiting. Efforts at xenotransplantation have proven disappointing because of a combination of immunologic and political barriers. The primary approach used to address the shortage has been to increase donor awareness, in essence, to ensure that more people realize the lack of personal harm and potential benefit of becoming a declared organ donor. Despite growing efforts, the donor pool has not grown significantly, and recent U.S. government initiatives have focused on creation of tax credits or direct payment to the families of organ donors as additional incentives.
In parallel to efforts to increase organ donation, the United Network for Organ Sharing registry continues to evaluate and test the system for equitable distribution of organs and prioritization of those waiting on lists. In doing so, fairness has been the key focus while trying to eliminate the temptations to manipulate the system to gain advantages for specific patients. Procurement and distribution regions exist on the basis of efficiency of administration and the limitations imposed by organ viability as they are transported from donor to recipient site. This is an important issue, as organs do not all travel equally well, and a heart needing to be transplanted within 6 hr is not available as widely as a liver that can have a 24-hr ischemic time. Therefore, organ distribution needs to be handled in light of this type of issue. For each organ system, priority for the recipients listed is based on the disease severity and the amount of time the individuals have spent on the list. For example, patients listed for heart transplant are placed into two major categories, status 1 or status 2. Although there are substratifications, those at the highest risk of dying, people supported by devices or infusions, are then further prioritized by how long they have been so ill. In this fashion, those who have been at the highest need for a transplant for the longest time are the people given priority to receive this limited life-sustaining treatment.
Somewhat less attention has been focused on the huge numbers of people who suffer from end-stage organ dysfunction who are not considered transplant candidates. For those with end-stage organ dysfunction, the addition of co-morbidities increases the risk of death resulting from the primary disease and reduces the success of transplant (3). Therefore, in light of the limited donor pool, significant co-morbidities and advanced age disqualify many potential transplant recipients. To date, there has been no estimate of the numbers of patients excluded, but guessing that it is at least 10 times the number listed would seem a conservative estimate. After all, 56,000 people died as a result of heart failure in 2000, (4) yet only 2,000 transplants were performed. In 1997, over 200,000 patients were receiving dialysis, yet only 12,445 kidney transplantations were performed (5).
This population is one rarely spoken of in the transplant literature, partly because of the clinical practice of limiting the treatment to ideal candidates because of the limited donor pool. The assumption has been that ideal candidates would benefit the most. These people in need who are not transplant candidates are a large enough population to stimulate investigation of both xenotransplantation and artificial organs as alternatives.
However, in contrast to the unknown of xenotransplantation and artificial organs, transplantation is a well-known discipline, supported by decades of research and clinical experience. Therefore, we also believe in the efforts of the past years to increase the use of this mature therapy as our primary goal. To that end, but not as an effort to diminish the importance of ongoing development of alternatives, we propose a revision of the transplant system, to increase the donor pool and safeguard equitable organ distribution.
Our proposal to improve the transplant system rests on a simple concept: If you are willing to get an organ, you should be willing to give one. This characteristic—the willingness to be an organ donor, and not how long someone has been sick—should determine the person who gets the highest priority as a recipient. In essence, if we sign a legally binding document now to become an organ donor in the event we are ever declared brain dead, and if we then develop end-stage organ dysfunction sufficient to warrant a transplant, we would get higher priority than others who have not made such a commitment. The amount of time since making this commitment would allow ranking of those within this higher priority group.
The system we propose fairly prioritizes patients, more so than counting the time since the arbitrary decision is made to officially “list” for transplant, and can be implemented with absolutely no harm to those already on the list. In this article, we describe how our proposal can be integrated within the current system while protecting the rights of those patients waiting for transplants. The spirit of this proposal can be applied to organ distribution as well. Most importantly, this system is one that will grow in its impact as people realize that such a commitment to become a donor—even if it never happens—can save their life or the life of their child.
INTEGRATION WITHIN THE CURRENT SYSTEM: HOW OUR PROPOSAL WORKS
Whenever proposing change to an established system, there will be resistance. However, if the long-term effects lead to improvement, and those who may suffer from a change are protected, the barriers need to be set aside. We believe that the only people who are at risk of harm by changing the system are those currently waiting for a transplant, who have been assessed and managed under the current system. If we change a rule that increases their wait significantly, they could die, and that is harm. In contrast, those of us working within the current system, perhaps dependent on it, would not be harmed by the change, only inconvenienced. Our plan can be implemented without the type of harm that would be important.
Protection of those waiting is an absolute requirement for any new system. Therefore, those on the list would be invited to have the first opportunity to sign up to become donors themselves, in the event they are unfortunate enough to become eligible. Once all listed patients have been given the opportunity to sign up, the process would be open to the general public. This ensures that those on the list now would retain their higher priority.
This approach establishes the precedent that even those in need of a transplant can become a donor and receive the higher priority ranking. Certainly, they are less likely to be able to provide ideal organs, given the typical age of transplant recipients, but these organs from older donors and even patients who have previously undergone a transplant (6) can function well and serve to expand the donor pool further, based on the unfortunate reality that hundreds of organs could be harvested from those dying while waiting.
This proposal rests on existing practices. Already there are central registries for organ transplant, and these registries need only minor changes to track the consents to become organ donors. Agreement on a driver’s license is already a part of our consciousness, and this is only a minor extension. In addition, standards of care exist already to limit therapies, especially with respect to transplantation, so we believe that adding this form of priority ranking would prove acceptable, even though some may consider it coercive; it does not prevent one from receiving transplantation if one does not want to participate. This is merely another form of managing the scarce resource. Using a person’s generosity as a part of subsequent ranking is already part of the renal transplant system. A living donor receives points that would subsequently elevate them on the waiting list if they were to develop renal failure necessitating a transplant (7).
The approach inherent in our proposal rewards selflessness even if, in practice, the primary motivation is self-interest. With such an approach, it becomes difficult to support a system of distribution tightly bound by geography that appears coincident with state lines. Regional organ distribution is necessary, but the regional boundaries should be a function of travel time based on specific formulas that will vary as a function of the specific organ in question.
THE NET EFFECT OF THIS PROPOSAL
When the first person receives a transplant very quickly after their need is established, with a wait time of days instead of months, the public attention will stimulate marked increase in the commitment of people to become organ donors. Of course, public awareness of this event will need to be encouraged by widespread and high-impact strategies.
We believe the system will start to gain enthusiasm quickly, with those people on waiting lists eager to join. In so doing, these people will help increase the donor pool within the first few months, as many will die before receiving a transplant. Even if this system failed, there would be little harm in its implementation other than the impact of forcing health care workers in the transplant field to change attitudes and some of their usual tasks. People in need of a transplant will not be hurt, and all of us stand to gain immensely from the shift to this new system. As the number of transplants increases, the personnel and hospitals involved will become more proficient and quality of care will increase, (8) much in the way that outcomes are better for other major procedures as volume increases (9).
SUMMARY
The major questions surrounding organ transplantation focus on increasing organ donation and ensuring fair allocation of this scarce resource. We believe that the highest priority should go to those who are most committed to such a therapy. Establishing this as a primary factor in determining priority will be a major incentive to increase organ donation from both altruists and those who want to protect their own future. Making this the major basis for receiving a transplant is fair and equitable, limits the impact of arbitrary or subjective criteria, and provides an incentive for greater organ donation, thereby adding to the fairness of organ allocation. Importantly, this revised system can be implemented with no harm.
For these reasons, we agree with others who advocate that ethical incentives are superior to financial inducements (2). Our plan is unique by identifying a simple and powerful ethical mandate: those willing to give an organ will be the first to receive one. This incentive will increase donation from both altruists and those who want to protect their own future, and lives will be saved.
REFERENCES
1. Scientific Registry of Transplant Recipients. About transplants: Fast facts. Available at:
http://www.ustransplant.org/facts.html. Accessed June 13, 2002.
2. Delmonico FL, Arnold R, Scheper-Hughes N, et al. Ethical incentives—not payment—for organ donation. N Engl J Med 2002; 346: 2002–2006.
3. Anguita M, Arizon JM, Valles F, et al. Influence on survival after heart transplantation of contraindications seen in transplant recipients. J Heart Lung Transplant 1992; 11: 708–715.
4. National Vital Statistics Reports. Deaths: Preliminary data for 2000; 49(12): 1–40, (PHS) 2001–1120. Available at:
http://www.cdc.gov/nchs/data/nvsr/nvsr49/nvsr49_12.pdf. Accessed June 13, 2002.
5. Collins AJ. End-stage renal disease: Are we ready for an emerging epidemic? Postgrad Med 2000; 108: 13–15.
6. Arvieux C, Cornforth B, Gunson B, et al. Use of grafts procured from organ transplant recipients. Transplantation 1999; 67: 1074–1077.
7. United Network for Organ Sharing Policies: 3.0 Organ Distribution, 2001. Available at:
http://www.unos.org/About/Frame_About.asp?SubCat=SubPolicies. Accessed June 13, 2002.
8. Dudley RA, Johansen KL, Brand R, et al. Selective referral to high-volume hospitals: Estimating potentially avoidable deaths. JAMA 2000; 283: 1159–1166.
9. Birkmeyer JD, Siewers AE, Finlayson EVA, et al. Hospital volume and surgical mortality in the United States. N Engl J Med 2002; 346: 1128–1137.