Utility vs. Equity: Transplantation in America Has Changed but A Lot of Work Still Needs to Be Done
Earlier this year, Lloyd E. Ratner, MD, Director of Renal and Pancreatic Transplantation at Columbia, was voted to the United Network for Organ Sharing (UNOS) board. UNOS is the private, non-profit organization that manages the entire system of organ transplantation for the United States through a contract with the federal government.
Dr. Ratner has worked with UNOS for decades. His mission has always been to get as many organs to as many people as efficiently and equitably as possible. Yet modern needs have outgrown the systems in place time and time again. So much has changed over the years, from transitioning to computers, to the internet, to the advancements in research that allow for less-than-perfect organs to be cleaned and transplanted successfully.
We spoke with Dr. Ratner about the latest changes to allocation boundaries for donor organs, all that’s transformed for the better, and everything that still needs to be done.
First things first, give us a brief description of UNOS.
UNOS has the contract from the federal government to run the Organ Procurement and Transplant Network, or the OPTN. A lot of people use the OPTN and UNOS interchangeably but UNOS is the not-for-profit organization, OPTN is the federal contract they hold.
When the National Organ Transplant Act was passed in 1984, they established the contract for the OPTN, and then that was awarded to UNOS. So, for all intents and purposes, UNOS started in 1986.
I know you've been fighting for new transplant guidelines for a long time. So, tell me a little bit about your history with UNOS before joining the board this year.
I was the UNOS regional counselor before. There are 11 UNOS regions, each region has a counselor who gets elected. You serve two years as the associate counselor, and the associate counselor sits on the membership and professional standards committee. So, they're the ones that review programs for how their outcomes are.
They review programs if they have changes in personnel, if they break the rules. They review new programs, too. After two years on that, the associate counselor ascends to the counselor, and the counselor spends a two-year term on the UNOS board.
Over the last 30+ years, how much has OPTN changed? What has changed?
Oh, dramatic changes. All kinds of policies in terms of allocation, logistics, distribution, but also quality for the programs have been amended—the bylaws. And the field has evolved dramatically over the last 40 years, there has been tremendous transformation.
Now, probably the biggest issue that UNOS deals with is allocation, and that’s changed a lot. Just the fact that back then everyone didn't have computers. There were these big mainframes, and that's why the way you could designate yourself as an organ donor was through the DMV. They had a computer and they kept track of people, where no one else did so. Everything has changed dramatically, maybe not as fast as we would like.
Has technological advancement really allowed for these big logistical changes to organ procurement that have been needed for so long?
Absolutely. I mean, the reason these geographic boundaries that made no sense were created is because they made administrative sense. But now, it's like, who in their right mind would put the DMV in the middle of organ donation?
We recently did an interview with Dr. Jean Emond about the new organ allocation boundaries that were long fought for — So, let’s see if I have this right: The policy was changed from receiving an organ only through the list held by each designated Organ Procurement Organization (OPO) where a recipient lives to potentially accessing any available donor organ in a 500-mile nautical radius or 250-mile radius of the donor hospital?
That’s it. I think it's helped us a lot. It's helped the whole New York area a lot. Now, by and large, the allocation goes from local to regional. Instead of local to regional to national. Before the change, our local area (supported by our local organ procurement organization) was New York City, Long Island, Westchester, Rockland, and five upstate counties…for a population of about 13 million people.
So back then, if a kidney was procured right on the other side of the George Washington Bridge, that we could look out the window and see in Teaneck, New Jersey, that kidney was more likely to go to Philadelphia or Pittsburgh or Baltimore because it was in a different region.
So, what happens in a place like New York City where there are multiple centers or hospitals so close within a radius?
Well, the logistics and the allocation algorithms become much more complicated. Before, it used to be that we only dealt with one organ procurement organization, and that OPO had 10 transplant centers locally. Now, for us, it's like 11 different organ procurement organizations, and they're dealing with like 60 or 70 transplant centers.
The complexity has increased dramatically. The amount of work and the phone calls have increased dramatically. So, we're having to add more staff and that sort of thing. But the end result is we're getting more organs, and we're getting better organs that didn't used to come to us.
How have the OPOs adapted to the increased complexity?
Good question. A lot of work that they used to do for us, like logistics and stuff like that, they don’t anymore. Now they say, "We don't have the bandwidth to do it." So, the centers have to pick up the work. That’s why we've had to add more staff and change our processes and change the way that the coordinators work when they're on call. Change the way the surgeons work when they're on call. We've had to make a lot of changes, but the net effect for the patient is really good.
Transplant Metrics and Political Impact
There are a few organizations that are big stakeholders in transplant, UNOS of course, but also on the clinician side, The American Society of Transplant Surgeons. You’ve served as leadership for that society as well, right? How has that impacted things?
I served three years as treasurer, and then treasurer automatically ascended to president-elected and president. In all these capacities I served on the executive committee, the governing body of the American Society of Transplant Surgeons. And as a major stakeholder in the transplant world, ultimately all these other things are superfluous if a surgeon doesn't get their ass out of bed and do the transplant. Ultimately that's the core thing. Transplant surgeons and transplantation existed before all these other things, you know?
And Columbia has had a lot of juice in the transplant world. We have what we call a Dead President’s Society in the American Society of Transplant Surgeons. Dr. Jean Emond and Dr. Mark Hardy, who really founded our transplant program, are also dead presidents. We’re one of the few organizations who have had three or more presidents.
What does political juice mean? How does the work of this executive committee benefit patients?
We've done things like meet with the head of Medicare, meet with the head of the Health Services Resource Administration (HSRA). I didn't do it, but my predecessor met with the Assistant Secretary of Health. And one of the things we talked about is metrics.
Up until now transplant programs were judged on their one and three-year patient survival, patient and transplant survivals. That’s all well and good if you've gotten a transplant, but if you're one of the people sitting on the list...I make the analogy, do you really care how good the education is at a particular school if your kid can't get in there? Who cares? I mean, it's all well and good that Harvard gives a great education, but if my kid can't go to Harvard, what do I care?
It's the same thing. If a patient can't get a transplant, why do they care how good the outcome is? So, if you're not taking that into consideration, who cares? It's not really reflective of the quality of a transplant program.
Right. Can you expand on that a bit?
We made these arguments to the people at Medicare, and actually we showed them that our particular center—even though we got flagged for having suboptimal outcomes, lower than expected outcomes on the one and three-year patient graft survival—we were able to show that we actually had a better overall patient survival.
That’s because we were more aggressive about using more organs and getting people transplanted faster. The suboptimal organs that we were using didn't perform as well as the optimal organs, and we got dinged for that, but they got more people transplanted. And more people did better by being off the list and getting transplanted. So shortly after presenting that data to CMS (the Center for Medicare & Medicaid Services), they got rid of their existing metrics for being certified for transplantation.
Wow. That’s great.
Another thing that happened is we met with the Centers for Disease Control (CDC). They had very stringent qualities about risk of transmission of infectious diseases. And we made the argument that they were too stringent.
A lot of these organs, although they may have been at somewhat higher risk for transmission of hepatitis B, hepatitis C, or HIV, the risk was still very low. And organs that could have helped people were getting trashed for a low likelihood of transmission for diseases that could be treated and managed anyway. We were able to get them to see the light and change things.
Let’s take a look to the future. What do you want to see change? What issues are you still working to fix?
The metrics are still problematic. We just had a big consensus conference about the metrics that was hosted by the Scientific Registry for Transplant Recipients. When they made the National Organ Transplant Act in 1984, they set up two contracts. One contract was for running the OPTN, and the other contract was to run the Scientific Registry of Transplant Recipients (SRTR)—a national database for all transplant recipients and donors.
Initially the SRTR was awarded to UNOS, and then 16-17 years ago they got challenged by another group out of the University of Michigan who held the contract for eight years. And then a group out of the University of Minnesota won the contract, and they hold it now.
When SRTS management contracts are shifting hands like that, are there benefits? Are there issues?
Well, there are issues. The Health Resources Service Administration (HRSA) who rewards the contract reviews the bids and picks the one that they liked the best. And I think collecting the data and analyzing the data is not as complicated as making the rules and running the whole system. That's one of the reasons why the SRTR contract has changed hands, but the OPTN contract has not.
Talking metrics, what are your goals? How do you want to tackle the problem?
We, collectively, as stakeholders, need to start with a goal-oriented approach. Do we want to do more transplants? Do we want to get more people transplanted faster? Do we want to reduce the number of organs that could be transplanted, but get discarded? We need a consensus around the goals and then define metrics that speak to those goals, rather than just have metrics that are sort of arbitrary. I think that's the important part.
I'm sure you have a personal perspective on what you find the most important. Would you share that?
I care more about access to transplantation, getting more people transplanted and care less about the quality afterwards. I have lots of goals about what allocation should be. Now allocation, at least for kidneys, is very heavily weighted toward equity.
Anytime you have scarce resources, you have equity and you have utility, and I think that they're sacrificing a lot of utility by focusing more on equity. And my point is equity is moot if there's no utility. If organs are being discarded, who cares that it's an equitable distribution of organs that don't get used? It makes no sense.
The way the system works now, particularly for kidneys, is based on waiting time. So, you wait eight years, let's say, and you get offered a crappy organ. I say this a lot, organs are like used cars. You're not getting a brand new one right from the factory, and they're very heterogeneous. Some have more mileage than others, some have been maintained better than others.
So, if you've waited eight years on the list and someone offers you an old beater, you can say, "Well, I'll wait two more weeks and I'll get the shiny Lexus with 20,000 miles on it. Why should I take this old beater?"
Then equity says, "Okay, if you go to the next person on the list who has a little bit less than eight years, and they say, "Well, I've waited almost eight years. I'll wait three more weeks, and I'll get the Lexus with 20,000 miles." Then you're going down the list, down the list, down the list, and now the organ's getting worse and worse because the amount of time it's been out of a living human being is increasing.
And the logistics are becoming more difficult because most of these organs, if they're being transported distances, are flying on commercial flights. Well, we all know commercial flights kind of stop at some time in the evening. So, then there's a 12-hour lag before they could get on another flight. The organs are getting worse and worse, which makes them less likely to be utilized.
Is what you’re saying that an overhaul to allocation policy could ensure that all of these organs are transplanted?
All of these organs, whether from an 18-year-old perfect donor or a 65-year-old diabetic with hypertension, could potentially be used. In Europe, they have a program that if it's an old donor, the kidneys go to an old recipient, they get allocated that way. That’s focusing on utility.
All other organs would, except for kidneys and pancreas, get allocated to the sickest patient first. But kidneys aren't allocated like that. There are those people who, if they had to wait five years, they're going to die. They're not going to make it five years on dialysis. So why not allocate these suboptimal organs to them first? I call it dealing from the bottom of the deck. And we've talked about this quite a lot. Why not allocate the organs most likely to be discarded to those people who could benefit from them?
Right. That makes a lot of sense. As you’re saying, you can’t have equity without utility. Where’s the balance?
You need to have the balance, and the balance needs to be adjusted. There are a lot of challenges facing UNOS now, because part of the problem is when you don't have enough organs to go around. Anytime you make changes, there are winners and losers. You're sort of redividing the pie. And I think it's really important to focus on growing the pie, and increasing the number of organs available. And one of the ways to do that, I think, is to focus more on living donation. That’s the other critical piece. And we’re dedicating all we have to using every resource available.