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Living Donor Protections Living Kidney Donor OPTN

A Small, Temporary Victory

It is rumored that HRSA has halted OPTN’s National Paired Kidney Pilot Project pending further investigation.

Paired Kidney Donation is when a prospective donor is incompatible with their intended recipient so these donor-recipient pairs are matched up (or chained) and a series of transplants take place as a result. Transplant surgeons/centers concocted this idea to increase the number of organ transplants (and earning them more $$) w/o thought to what this would mean for the living donors.

Here’s why HRSA did the right thing:

1. Although it was referred to as a “project”, it was not conforming to federal laws pertaining to research studies using human subjects.

2. Only 4 transplant centers were participating. The is not a big enough sample size to render valid data.

3. Of the four, two were on the east coast and two were on the west. This meant donor organs would be transported across the country, increasing ischemic time (time an organ spends outside of a living body). The longer the ischemic time, the less the benefit of it originating from a living donor.

4. The project contained no safeguards for living donors. The pressure to donate to an intended recipient (esp if a relative/loved one) is huge; imagine how suffocating it would be if your donation affected an entire chain of donors/recipients?

5. The project did not standardize prospective living donor evaluation processes. Every transplant center could make their own rules/policies, thereby rendering the resulting data inconsistent and invalid.

6. The project did not provide for living donor aftercare. Once again, a living donor’s physical and psychosocial well-being was inconsequential as long as ‘sick’ recipients received their transplants (and transplant centers were well paid).

7. OPTN was never intended to oversee living donation. It was created to form and manage deceased organ donation and the deceased organ waiting list (UNOS). They were charged with the responsibility of maximizing deceased organ donors and the ‘equal’ allocation of deceased organs. (see NOTA – national organ transplant act) In recent years, they have been encroaching on living donation/donor issues, but only as long as it benefits their end – procuring more organs for transplant. They resist every effort made by advocates to ensure the safety, protection, and support of living donors.

Considering that some transplant centers have already networked to engage in their own Paired Kidney Donations, the pressure for OPTN or some public policy organization to develop a national program is immense. Before that happens, current law must provide for an independent agency to oversee living donors and ensure our short and long-term health and well-being. Only when living donors are treated as equal partners in the transplant transaction should any project or policy to ‘expand’ living donation be considered. Anything else is simply unacceptable.

{side note: apparently at an August 28th HRSA meeting, one member remarked on the ‘unexpected swell of living donor advocates’. Good. Maybe they’ll start taking us seriously}

2 replies on “A Small, Temporary Victory”

Christy, Thank you for posting about this important topic.

I would like to explain a few things you mention in your post, and yes, I work with one of the centers selected for the UNOS pilot project, so I want to state that up front.

1) All consent forms that donors/recipients sign (at least with the centers that work witn the Alliance for Paired Donation) most certainly are vetted through the transplant center's institutional review board, thus all must comply with federal law pertaining to human subjects. I am confident that the centers participating in the other paired donation networks follow the same standards, but patients can certainly check this out when learning more about participating in a paired donation program.

2) The four centers participating are actually much more than single centers. For instance, the Alliance was notified that we were selected as a "coordinating center", meaning any of our 80+ transplant centers that agree to abide by the UNOS operational guidelines for the project can enroll pairs. We have already had 43 sign an authorization form saying they would enroll pairs – centers from California to Oregon to Texas, Ohio, Florida, and in between. The other centers include another paired donation consortium plus two very large single centers.

3. In your statement 4, I believe this is totally untrue. UNOS has published documentation on living donor safety and followup and the KPD pilot program will adhere to the living donor guidelines (i.e. the "Resource Document") UNOS has developed.

4. Concerning your statement # 5 – all participating centers (not just the coordinating members, like the APD, but the individual centers) must agree to abide by the UNOS operational guidelines. This is published on the UNOS Web site if you would like to take a look. http://www.unos.org/ContentDocuments/KPD_RFP_070709.pdf

5. While I agree that initially the OPTN (which currently is UNOS) was not mandated to oversee living donation, this has changed in recent years. The secretary of HHS is requiring UNOS to get involved in living donation, and more recently paired donation. UNOS was unwilling to get involved until the passage of the Charlie Norwood Act clarified that living donation did not violate NOTA.

I believe we still have a long way to go to come up with a national paired donation program that will increase access to care for recipients. But I think the pilot program is a good first step.

And yes, we must build in safeguards for the donors at every step of the way.

Laurie Reece
Alliance for Paired Donation
http://www.paireddonation.org

This is where you and I disagree. I think living donors' safety is paramount, where you and others interested in Paired Donation put the recipient first.

Kidneys are not the same as hearts; there are other treatments for people with end-stage renal disease. A person in need of a heart will die without out one. On other hand, a person can live a long time on dialysis. In fact, recent data on peritoneal dialysis produces the same success rates as transplants (and no healthy people have to maimed in the process)

Housawi's study clearly revealed that surgeons vary in what risks they disclose to living donors, which is a direct result of UNOS/OPTN's lax policies and non-existent quality control.

If the Alliance for Paired Donation (or other orgs) were so concerned with living donors, they would track them long-term, and provide psychological services and follow-up, which clearly does not happen despite the evidence that some LDs suffer from depression, anxiety, anger and PTSD.

Until those systemic deficiences are resolved, I will not support any expansion of living donation.

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