Ms. Zill sent me a copy of the missive she submitted to UNOS and asked if I could publish it here:
Attention: Kidney Transplant Committee Liaison
United Network for Organ Sharing
700 N 4th Street
Richmond, VA 23219
Re: Concepts in Kidney Allocation
March 27, 2011
I thank the Kidney Transplantation Committee for the opportunity to comment on, “Concepts in Kidney Allocation.” I would like to focus on provisions made for prior donors who progress to kidney failure.
Mr. Ron Herrick, the first living kidney donor, died in December of 2010 while on dialysis. Prior to this he had suffered from cardiovascular disease for over a decade. This news is alarming because of what it may portend for aging kidney donors.
Although transplantation is often described as miracle for the recipient, rarely is it mentioned, even to kidney donors, that:
“Every kidney donor will experience a decrease in the kidney function compared to pre- donation. The amount will depend upon the potential donor’s age and history. The anticipated change in their individual kidney function is to be discussed with each donor…potential for organ failure and the need for a future organ transplant for the donor…potential for other medical complications including long-term complications currently unforeseen.” (OPTN Guidance Document for the Informed Consent of Living Donors, 2009”)
Instead, there is a common misconception that the remaining kidney grows to do the work of two, which is perpetuated by transplant professionals and is often restated in the media. There is also the understanding among many living donors and their recipients, that if a prior living organ donor progresses to kidney failure, they will be given priority on the national wait list.
Many kidney donors have renal insufficiency, which is compounded by normal age related decline in renal function. Reduced renal mass does increase risk for ESRD. When life is donated, it means that to some degree, risk is shared.
In 2008 a Living Donor Data Task Force (LDDTF) of OPTN found that the data reported by transplant centers are incomplete and cannot be used for research or to make conclusions about the long-term safety of living organ donation. Recently completed studies from sources other than OPTN data are limited due to short duration of follow up and selection bias in transplant centers studied. Peer reviewed articles that cite OPTN data have used non-representative data sets. And, the mounting body of literature about superior survival with nephron sparing surgery in cases of incarcerated renal cell carcinoma is directly relevant to living kidney donors.
While it is true that many donors have positive experiences, there is an ethical concern about the scientific information used to obtain informed consent because long-term risk remains undefined and/or not quantified, and therefore, are not yet remediated. Ethical concerns also exist because the national transplant system lacks preparedness to manage adverse outcomes in prior living organ donors.
The Guidance for the Medical Evaluation of Living Kidney Donors and Guidance for the Informed Consent of Living Donors, developed by the Living Donor Committee between 2007-2009, are only model documents to be used in a voluntary fashion by centers. Kidney donors are entering a national system with clear variation in practice standards across centers, but many are unaware of this. There is a belief among recipients and donors that practice regarding living organ donors is standardized, including how they will be managed on the wait list if they have kidney failure. I believed this when I donated in 1991. My recipient told me the Medicaid manual instructed him to find a living donor. I believed that there was a system in place to take care of me if I progressed to organ failure, and that I would be given some priority on the national wait list.
Despite the altruism of living organ donors and the belief among them that they will receive some priority on the national wait list if they progress to organ failure, it appears that the concept under consideration will actually adversely impact donors who develop organ failure.
For living donors, time from donation–age increases risk for ESRD. Centers routinely accept middle age donors and older, but the remaining kidney of older donors do not hyper filter as well as those of younger donors. The conceptual changes under consideration disadvantage candidates who are older exactly when prior donors are most vulnerable. It also does not address the reality that the normal lifespan of a prior donor with organ failure has been adversely impacted by the donation. This seems unfair, and adds another variable to this fragile and difficult calculus.
The conceptual changes under consideration do not incorporate prior donors into a national ranking for an organ in order to meaningfully prioritize them. It fails to make provisions for the current expectation that living donors will be given national priority based upon wait time.
In this way it leaves them exceptionally vulnerable to geographic variability in organ availability; it is akin to a broken promise to prior donors and their recipients, betrays their trust in the transplant community, and does not enhance the public’s perception of the nation’s system of transplantation.
Consequently, the concepts under consideration lack institutional fairness to living donors who have put their faith in this system, even though their families’, careers, retirement plans, and dreams depend upon the integrity of the transplant system.
The actual number of former donors needing a transplant is irrelevant in the design of a new allocation system. It is the ethical obligation to care for donors who have placed their trust in a system that is paramount. This is especially critical because their informed consent has not been based upon representative data.
Also, as currently conceptualized, these changes will unnecessarily complicate and obscure national data on long-term donor outcomes because prior donors in need of a transplant will be assigned as a local concern, rather than a national concern.
We need national data on living organ donors and a consistent national approach to manage living organ donors. Kidney paired donation will take donors to all parts of the country, will expose them to wide variation in center practice, leave them vulnerable to the vagaries of their recipient’s health insurance plan, and leave them without a consistent plan for follow-up.
And, although the Kidney Committee has learned, “that most stakeholders desire an allocation system that is straightforward and easy to understand,” the management of prior living organ donors listed for transplant within, “Concepts for Kidney Allocation,” is not easy to understand.
Future conceptual changes in the allocation system that utilize a model trajectory of prior donors who progress to organ failure would be an interesting contribution to policy creation about living organ donors. This would also lend some needed transparency regarding the care of living donors.
Currently, OPTN policy developments regarding living donors are inconsistent and haphazard. For example, there is an OPTN policy proposal about data collection of living organ donors currently posted for public comment. This policy would require the center that conducts the donation surgery to also facilitate data collection for two years. It is described as a strategy to enhance continuity of medical care (which is desperately needed for kidney donors) and to increase center accountability for donor outcomes. But, remarkably, it does not create provisions for continued medical care, only data collection. For those who donate at centers away from their home, as will many who participate in kidney paired donation, there may not be local, medical follow-up.
And, after two years, the donor will be lost to follow-up unless they progress to organ failure. So, although the proposal on data collection recognizes the need for donor data, need for continuity of care, and emphasizes center accountability for donors, the changes under consideration in the allocation policy do not address continuity of care for prior donors with organ failure, would obscure a national accounting of living organ donors in need of a transplant, does not hold centers accountable to their donors with organ failure (but leave them to local DSAs), and is counterproductive to the need for national transparency about living organ donor outcomes.
Human beings are not medical supplies. The public cannot be asked to consider living organ donation in a national system that does not optimally manage their care, especially in the acknowledged, but not yet quantified, contingency of organ failure. The miracle of transplantation and the need for donor organs are not justifications to marginalize former donors in need of a transplant.
Donor altruism, “good faith” in the promotion of living organ donation as a safe procedure, and commitment to public safety require careful consideration of the needs of prior donors within a national system to allocate deceased donor organs. A more detailed explanation of the management of prior living organ donors in need of a transplant is needed, which reflects care and respect for the approximately 100,000 living kidney donors that have enhanced lives and contributed to the enterprise of transplantation.
And, although the Kidney Committee has undertaken a herculean task to address shortcomings in the current system of allocation of deceased donor organs, it leaves many dissatisfied. This may be so because the concepts under consideration primarily address characteristics of the candidate and donor populations, which create the appearance to the public that needed technical and system changes are underappreciated or not recognized. This does not reflect positively on the practice of transplantation in this country. Perhaps these proposed concepts would be less controversial if they included conceptual changes within OPO and center practice to improve the entire system of the allocation of deceased donor organs.
Jane Zill, L.I.C.S.W.
UNOS/OPTN, Living Donor Committee (2007-2009)
UNOS/OPTN, Living Donor Data Task Force (2008)