 Good afternoon. I'm delighted to welcome you to today's seminar on ethical issues and organ transplantation. We're delighted and honored that Dick Thistlethwaite will present the talk today on a more equitable and efficient system for kidney allocation. Dick and I go back quite away. We worked on some projects together in the 1980s when Dick performed the first pancreatic transplant in Illinois and was a member of the team that performed the first liver transplant in Illinois. He also was a member of the team that did the first living donor transplant in the program here at the University of Chicago. Dick is a professor of surgery, a professor in the committee on immunology who received his MD and PhD from Duke and then did his residency in fellowship training at the Mass General and the NIH. Dick has performed more than 1500 transplants, kidneys, pancreas, livers, and conducts research on T-cell receptors and co-receptors to develop biological reagents that can prevent transplant rejection. He and I also worked together for six years in the Immune Tolerance Project, something that came out of the University of Chicago. Dick has had many positions of distinction. I'll just mention a few. He's been president of the International Pediatric Transplant Association and the Illinois Transplant Society. He has been the board chair for the regional organ bank of Illinois and has served as a governor of the American College of Physicians. Please join me in welcoming Dick Thistle-Tway. That was American College of Surgeons. I don't qualify for this. All right, so what I'm going to do is talking about a, in part at least, about a way of allocating organs based on donor and recipient age that we call age mapping, that I've been very fortunate to work with Lainey to develop. But a large part of the talk is going to be about sort of, about current algorithms of allocation of disease donor kidneys and an attempt that's been ongoing for several years by UNOS to create new algorithms that will be more efficient. And I hope I can convince you that both equity and efficiency considerations are compatible, at least with age mapping, although I think somewhat questionable with the proposals that have been made through the kidney transplant committee of UNOS recently. This is not just an ethics issue. It's an issue of law that the National Organ Transplant Act, which is actually a law passed by Congress, demands equitable access to patients to organ transplantation and equitable allocation of organs. So trying to figure out ways to get equal access is very important. Now, more recently by government regulation, federal regulation, not only has equitable allocation been restressed, but notice at the bottom in red, the issue of proficiency, the best use to donated organs has also been raised. And this has been really a decade-long struggle for UNOS, the group that oversees organ allocation in the United States, to try to come up with ways to do this. I might add that in different organs, this has been approached differently. How we do things in kidney is different from life-saving organs because of the alternative of dialysis. But still, since we are talking about a shortage of organs, an important way to figure out how to ration organs in the best possible fashion. My collaborators, Lanie I mentioned already, Will Parker, who is a first-year intern in medicine here during an elective period as a fourth-year student here, did a lot of the mathematical work of the model I'll show you. Bob Beach is an ethicist and a longtime friend of Lanie's from Georgetown, who helped us with the ethical considerations for age mapping. Summer Gentry is a mathematician, statistician and modeler from the Naval Academy, who I had heard give a talk several years ago that I was impressed with, and that Lanie said, well, let's call her, and we got her involved without ever having met her to help Will with the mathematical modeling. And then Ben Hippen is an aphrologist from the Carolina's Medical Center in North Carolina, Charlotte, North Carolina, who actually, in the early part of the project, worked with us and did a lot of the statistical analysis in terms of looking at the UNO's proposal and critiquing it. Well, if you haven't gotten, if you've gotten anything out of the seminar series, it's there aren't enough organs. And if there were, no one would argue about allocation at all, we'd all be happy and we'd be transplanting. And there wouldn't be federal laws or regulations governing transplantation, that is over and above what we're all facing now in the rest of medicine. But it's been a fact of life for us for a long time. This demonstrates graphically that the waiting list keeps growing, the number of kidney transplants remains stagnant. And the only real point to make from this is actually how good the nephrologists are of keeping people's renal failure alive now. Because despite the increasing disparity, you notice the death rate on dialysis has not changed. Well, just some general things. There are multiple approaches to trying to increase the supply of organ donors. Non-heart beating donors now, which we refer to as DCD. These are people that don't quite meet brain death criteria, but whose families have determined they want to withdraw active treatment for supportive care now make up about 10% of all organ donors. Excuse me, yes, 10% of all organ donors. In this hospital, I want to mention that Tracy Kugler was instrumental in developing our DCD policy here. First person consent remains controversial if you sign and get on a registry in your state for to be an organ donor. That now legally takes precedent over the wishes of your families after your death. It's a mixed blessing. Yes, we can force one more donor, but to the news media loves to publicize these events, which probably then prevents several more people or families from donating. Presume consent is more of a European model, which is an opt out. In other words, you're presumed to be a donor unless you have stated beforehand you don't want to be. And in Spain, where it's most successful, it's combined with actually having in each hospital in Spain a paid employee whose job is to identify donors and help have potential donors actually become donors. Spain, because of this, is the most successful country in the world. In terms of donors per million, with about 45 donors per million population, the U.S. is somewhere around 30. So in other words, they do about 50% better than we do. Something that actually just this week was introduced as a bill to Congress is the to try to reverse a law which prevents HIV positive people from being organ donors. The concept here would be to allow HIV positive donors to give to HIV positive recipients, which now at least for our program is about 5% of our kidney transplants are in HIV positive patients. So this would again increase the availability of organs for everyone. I think it's conceivable with the improved retrovirals, by the way, that in the future you could envision giving HIV positive organs to individuals who were HIV negative and treating them prophylactically. And that probably even today would work, I think, intellectually and emotionally. It's probably not an acceptable thing right now, but theoretically it could be. And in fact, as I talked some about older donors, I suspect an older recipient, I suspect a lot of older recipients would do better with that sort of donor from a young person than with an old donor because of the efficacy of current treatment. Economic incentives, I might mention that Frank Delmonico, the keynote speaker of this series, about ten years ago proposed that there be a donation made to families of deceased donors for funeral expenses as a thank you, in other words as a payment, didn't go very far. And finally, Lanie has mentioned the possibility of revising the brain death criteria to that of cortical brain activity. I'm not sure how many new donors this would bring because this would just convert what we now do as DCD donors basically into a redefined brain death donor status. Living donors, although it's still a very small number, the non-directed donor altruistic donor has become increasingly a donor source. And as we heard Garrett Hill talk about in his business model of donor chains earlier in this series can be magnified many times over in terms of one donation starting a whole chain of exchanging of donors among living donors who are incompatible with their emotionally related recipient. And finally the whole, the big elephant in this refrigerator is the idea of paying for donors themselves. It's a very emotional argument on both sides. Those four can see how we would have enough donors to to transplant everyone needed at least for kidneys. I don't think we're talking about heart donors here or lung donors but and note that we do have hazard pay for several other risky things that we allow individuals to undertake. Those opposed to it talk about the privilege praying on the underprivileged because certainly the people who would volunteer to give up their organs for money for the amounts of money likely to be offered at least because I suspect we all have our price. But the price that would probably be given would be those of the poor. Just as a side Lady now has a journal book club I guess that has met twice trying to look into the underpinnings of payment and the possibility of this or the ethics of why it shouldn't be done to try to get a more reasoned approach than what we've heard publicly. I'm going to probably skip this slide because I have a lot of slides other than the very bottom which says actually and what we're going to talk about is one of the ways to help not resolve but help with the organ donor shortage is to change the allocation algorithm to favor optimal candidates. And I think this slide this next slide will help you understand that if you look at the most frequent cause of failure of kidney transplants and this comes from an article very good article actually out of the Mayo Clinic where they had biopsy data on failing kidneys. But you can see by far and away the most common cause of a kidney of a kidney failure is death with a functional kidney. That means that the kidney could have worked longer. Now I can quibble with some of their percentages they have a different patient population than us and they take different risks because we don't have 11 or 12 percent of our patients have no primary non-functional with disease donor kidney transplants. I think we would find that unacceptable and I believe if I ask Michelle who oversees our transplant follow-up Michelle Josephson I believe we probably have more than 11 percent of our patients with chronic rejection also. So there are some differences in populations and how you approach but the astounding factor is that a lot of kidneys go into the ground into the grave they could still be working for someone else if they were put into a more appropriately matched recipient. Let's just review kidney allocation now. Since 2002 there have been two types of donors primarily standard criteria donors that's the majority and about 16 percent of donors called extended criteria donors. That's all donors greater than 60 year old or greater than 50 with the caveats noted. It requires an opt-in by sign consent to get a expanded criteria donor. This is because statistically and they were chosen as an expanded criteria donor they have a relative risk of graft failure at least 1.7 times that of an ideal donor. Now that statistic is not limited to expanded criteria donors. If you look at standard criteria donors about 30 percent of them also hit that level of a relative risk of graft loss of 1.7 percent but virtually all expanded criteria donors hit that and have that risk or higher. The distribution algorithm which is the baseline financial move is a point system where waiting time is the most important gets you the most points. The longer you waited the more likely you are to be offered a transplant. Queuing waiting is an equity way of doing it. Everybody gets their chance you get in line and you take your chance of getting to the end of the line and getting a transplant. There are some points given for efficacy and that's HLA matching primarily. That used to be a big deal as immunosuppression has gotten better it's not nearly as much of a deal as it is now in fact only HLA DR matching not AB or DQDP or others are used in the algorithm and also and this is probably a good thing within each category there is varying quality so when I get offered a kidney in the middle of the night it may be a standard criteria donor kidney from a 20 year old who has no cool mobilities other than having been in a traumatic accident or it may be from a 65 year old who's had a stroke had hypertension may have diabetes so there is a varying quality and that again is sort of a lottery which is another equity measure but equity drives pretty much the current system rather than efficiency. So in 2011 the kidney committee KTC kidney transplant committee of UNOS presented a concept paper with a proposal to totally change how we distribute kidneys. So first the top 20 percent of kidneys by what's called a kidney donor profile index and I'll explain these terms would be given to the top 20 percent of recipients best as determined by their estimated post-transplant survival. So just take the best and give to the best in other words off the top. This remaining 80 percent of kidneys would be distributed by age matching with a range on either side of 15 years which would give younger kidneys to younger recipients and hopefully improve efficiency. So this raised the two questions because it's a two different scheme for a lay side by side is giving the best kidney to the best candidate ethically justifiable and is giving the younger kidneys to younger donors ethically justifiable. This is each of these is a question in two parts because one is a general question and the other is looking at the specific criteria that UNOS set to try to incorporate these. Now for me I have trouble with the first one best to best is not sort of how we do medicine it's sort of the neediest first. The second I would argue that in theory there is not a problem with giving younger kidneys to younger recipients indeed that's the age mapping proposal that I'll talk to you about. It makes it easier because I think the specifics of how UNOS has done each of these or proposed to do each of these is flawed. So let's talk about longevity matching. The kidney donor profile index is to be an estimate of donor kidney not survival not the recipient survival in terms of longevity but just the kidney survival has 10 different factors that are only donor based and you can argue with the individual factors but if you plot the relative risk of graft failure versus the percentile by this KDPI index and it's an index over 100 percent so if someone's at 80 percent it means 80 percent of the kidneys or kidneys at 80 percent 80 percent of the kidneys are estimated to perform better predicted to perform better than that kidney. Now you can see the real problem of this as far as I'm concerned is actually out at the tail where the among the worst kidneys and you can read from that the kidneys that older people are going to get meaning people like me and what they want to do is limit at least distribution to the bottom 20 percent best to best but since the KDPI we will talk a little bit about the upper end as we move along as well now the estimated post transplant survival is only based on four factors age time of dialysis prior transplant and diabetes and obviously each of these factors make post transplant survival worse and we'll talk about that as well now if you look at this in terms of median estimated post transplant lifespan you can see that indeed some kidneys excuse me some kidneys are estimated to work much better I would argue that the top 10 percent is looks different than the top 20 percent because the second decile it looks pretty much on a linear curve with the others the justification given interesting and this is this is actually a quote is the reason they the top 20 percent was selected was for no other reason that it was determined to be the most discernibly different from the rest of the kidneys and I think as we'll talk about that is an issue a busy slide I've just talked about the arbitrary dichotomous division between 20 and 80 percent is having no justification ethically about why the it is a 20 percent having virtually no justification other reasons is methodologically the statistical evaluation is lacking this is a test to remember to determine who gets a kidney so a medical test that can pick out the top quintile from the bottom quintile but not people in two successive quintiles so in other words you're going to treat similar people differently based on a measure that cannot make that distinction I put this bottom paraphrase actually here because Alan Lightman who talked to us a few weeks ago was a member of the group that helped develop the precursors for both EPTS and KDPI and is an author on this critique stating essentially what I have already so one of the things that I wanted to point out about the upper end of that curve is that KDPI is calculated without consideration for candidate factors that decrease graph survival from the earlier slide where I talked about death with a functioning kidney which is what we're trying to overcome that's mostly older people who basically their kidney could outlive that's a recipient factor so this formula that ignores that makes it look like the worst kidneys which by our current system which is where this is modeled from meaning the expanded criteria donor kidneys are the ones that fit into that category and we're digging them even excessively by the formula because we don't take into account that many of those kidneys would actually last longer if put into people who would live longer and I think I showed that slide again one and concentrate up here that certainly it is going to keep going up but I don't think it's going to go up so expeditious what's the difference try convincing a kidney recipient they want one of these kidneys and we're going to discard kidneys because of the way we're presenting the data to them and I don't think adequately analyzing it for the patients the bottom point even the kidney committee of UNOS admits that they have not really vetted or validated the estimated post transplant survival this is their quote and I think again having ideas presenting them is great but not saying this is how we want to distribute kidneys when it's not actually been a validated measure diabetes remember one of the four things that go into estimated post transplant survival how can you pick the most prevalent disease that causes kidney failure and make that as a discriminating factor it actually isn't the discriminating factor is cardiovascular disease that's what causes people to die before whether kidney is still working not diabetes yes diabetes have a lot of cardiovascular disease but so do other people the problem is that UNOS doesn't collect data on cardiovascular disease to be able to use it as a discriminating factor and this is the closest they get so that they will pick to discriminate against a disease people with a certain disease in order to try to have it as a surrogate for another model because the diabetes if you look at the multiplication factors it's not just 25 percent of its time on dialysis and 25 percent of its age etc age and diabetes are the two strongest drivers of EPTS and it will disqualify even young diabetics from being in that top 20 percent it will also along with the age plus minus 15 age discrimination when they looked at what's going to happen to various diseases and who will get transplanted diabetes is the only disease among the major diseases that cause kidney failure that will be discriminated that's because it's primarily type 2 diabetes which far out numbers type one is primarily an older population so that's as much age matching it as it is the 20 percent now they really unfortunate thing is that they have chosen in this to look at survival from time of transplant if you look at earlier data looked at survival from time of starting dialysis of development of end stage renal disease transplant makes a tremendous difference to people with diabetes if you look at lifespan from listing with no transplant these are people who are highly sensitized have hard time getting a recipient you can see that in young people their time that they would live just on dialysis is less than half of that of someone who doesn't have diabetes it's reduced in middle age people and really only starts to almost become the same in old people but still a decrease if you look at life years gained with transplant it's the diabetics who gained more life years with transplant again until you get to the very old so that it's actually imperative that we try to get your diabetics transplanted because they benefit so much from it and this is totally ignored by simply looking at time from transplant rather than the time of development of renal disease the final thing that's just I think probably for lady more than anything else is they actually present this data in their proposal and that is the improvement of their hybrid proposal over baseline meaning what the current way kidneys are distributed there are life years gained there's no doubt about that compared to baseline but if you look on a per patient basis relatively small gains if you look at life span benefit of transplant versus dialysis for example it's a half year that's gained that would be 5.4 versus 4.9 but the most amazing thing is if you said let's do away with this 20 percent of giving best to best because of all the concerns I mentioned and just did age matching you would see absolutely no difference and if you compare those two columns you can see there's virtually no difference between the two so in in the concept proposal the justification they are having presented this data that they gave for the hybrid proposal was that it gave them increased flexibility I don't know what that means but that was the only stated benefit and and actually there is none so let's talk about age matching I can trash that too if you are going to age match you have to consider what are the age distributions of your donors and recipients because and actually the one of the first papers Mark and I worked on had to do with age matching of liver pediatric liver transplant recipients and brain death donors of pediatric age and there was a great mismatch here there's a great mismatch also if you look at donors first thing I want to point out is that this is not the number of donors this is 10 times the number of donors so when you see this peak at 3000 and this one almost is 3000 think of it actually being down here at 300 okay so in other words there are far more recipients than donors but in order to show the peaks and they're actually three there's a small peak due to unfortunately due to infant death there is a large peak due to trauma among young people and there's a large peak due to cerebral vascular accidents among old people now obviously 50 is not the and I'm looking from the side is not the peak of that disease but there tend to be core mobilities in people with cerebral vascular accidents from older age that make them disqualify them as donors both these peaks are younger than the peak of recipients so if you did strict age matching year for year here and you were say 20 years old you'd have enough donors so because this is really remember 300 not 3000 you'd have about the same number each year of 20 year olds who needed transplants and donors who were 20 years old if you go out let's say to 65 where donors here that read 500 would be really 50 and you by comparison have 2000 recipients vying for those 50 transplants so very inequitable hence the plus minus 15 years to try to smooth that out it doesn't really smooth that it out however because even with the plus minus 15 years if you look at the number of transplants per the number of candidates and these age ranges were chosen by unison will continue to use those further so we can do comparisons it looks like the youngest age range 18 30 to 34 year old candidate would have an over three times chance of getting transplanted than someone who is in the highest age range of over 65 so this is just age discrimination so not only is it because of the mismatch in ages of donors and recipients preferentially giving more kidneys to younger as age discrimination but there's another unintended consequence here and I bring these up because Laney loves unintended consequences and that that is that if you give fewer kidneys to older people their weights will be longer these are the people who are most likely to die while waiting and therefore you're going to increase your death on the waste list that statistic that's remained relatively stable for a long time so this is not a good thing to do now in the public comment period which the way Unis does is they put out these proposals they allow public comment in the public comment period the office of general counsel in the office of civil rights of HHS commented and you can read their comment saying this is it does not meet with the requirements of the age discrimination act of 1979 and likely to bring lawsuits and that killed this proposal I'm sure they didn't listen to Laney in my comments but they listened to to the government's the government gave them an out and actually stated that stipulations in the age discrimination act allowed that age can be employed if it's used as a proxy for medical variables it was like a lifeline being thrown out to them they didn't take it but nonetheless it was there well Laney and I looked at this and as you can see I've been very critical if she were giving this talk I think it'd probably be up a notch or two it's easy to pick out flaws and other people's ideas it's much harder to be constructive about how you might be able to help them improve on it and we looked at the two parts of the proposal and neither of us saw a way that we could clearly ethically justify best to best people may agree with that certainly the creators of that algorithm disagree with that but at least with our feet being soundly based in equity that didn't seem to be the right thing so we asked each other and both of us sort of came up with this idea at the same time what can we do because age is very appealing number one as I say here we all age is something that happens to everybody it's not taking diabetics versus non-diabetics tomorrow we're all going to be a day older but two and we had realized this actually and begun an opinion piece actually we're on about its 20th version by the time the the government statement came out that it is a good surrogate for both donor graft survival and candidate lifespan and it should even though I don't think I had any idea it was in the age discrimination act of 1979 it should meet those requirements so this is actually a graft of hazard ratio of donor age and graft survival in the paper that first proposed the precursor to KDPI and they even admitted in that paper and this is again the the Michigan group that there was a great relationship indeed you saw from about 10 to 40 or 10 to 35 years of age that there was about the same hazard ratio there wasn't a difference but above that almost a linear relationship with age and the then the graft survival of that transplant when it was transplanted Laney presented this slide two weeks ago and I presented it only because she couldn't find the 18 to 34 year old donors I don't know if you remember that but she was searching around for this dotted purple line and the reason she couldn't find it is it's because it's hidden by the solid purple line which is the 10 to 17 year old donors there is just no difference in survival when you plot out this was 10 years of the UNOS database that we plotted out ourselves successively older groups of donors have successively worse survival much consistent with the hazards ratio that I just showed you but it really is equivalent a donor who's 18 and a don't up to 34 that it's even if you plot that out by smaller increments there's very little change as the hazard ratios would suggest UNOS actually looked at age as a similar variable and compared it to KDPI forget the kids they did this wrong they're this is all mild remember so if you don't have a good model their model doesn't work for children and indeed one of the things as well as subsequently done is gone and looked at kids and with more granularity you can pick out even some people from donors from zero to four years of age that if you do dual transplants or unblocked transplants do just as well as the 11 to 35 year old but look at the adults and you can see again there's a linear relationship between donor quality as measured by their KDPI and age itself so that KDPI adds very little to age now they want us to see that there's a substantial overlap as a negative advantage I see it as a positive advantage and again I go back to my statement we want to treat similar people in a similar fashion and by having that wiggle room and I think they didn't describe it but I believe these are the lines are outliers the bars are probably 70 and 25th percentile and the middle line is median by having that variation in quality it makes one group closer to the next and so there's not as much discrimination because of that sort of lottery effect that we even talked about earlier with the current system what about lifetime this is another slide from UNOS they shoot themselves in the foot a lot and that is looking and expected remaining lifetimes from people starting dialysis from people getting transplanted and age match normal controls now I want to focus primarily on the green line obviously to again point out that there with age there is a incremental decrement in lifespan so this is the EPTS which age is a good surrogate for this is not all that accurate for comparison because this is all people on dialysis not all people on dialysis are healthy enough to get a transplant so it's not a good comparator but it does worse obviously and again the focus for patients is when I show them this graph they're not going to be as good as if they had their own kidneys working normally for them but still age is a good surrogate for outcome in terms of post-transplant survival so the development of age mapping for us was really a two-step process the first was to create an ethical framework that would say that it's okay to use age as a discriminating factor without it being discriminating to use the word two different ways and the second when Will came as a fourth year student during his elective period to work with us with a lot of math mathematical expertise that we claimed we had forgotten but probably actually never really had we were able to actually generate a model for this perhaps it should say oversimplified rather than simplified there so one of the things you have to know about Laney is when she gets into something she takes a mini sabbatical so one weekend Laney came to me and said I need to read about rationing of scarce resources and I have this mental image of her locking herself up in a room at home and ignoring her kids and her husband and and reading about rationing of scarce medical resources one of the things she came back with after that weekend was this article by Prasad at all which was essentially about how you allocate scarce medical resources not necessarily transplant organs although that was one of the examples he used and although he didn't agree with all the principles he enumerated I think this statement is very true to achieve just allocation of scarce medical intervention society must embrace the challenges of implementing coherent multi-principle framework rather than relying on simple principles or retreating into the status quo we do a lot of retreating into the status quo I think if you look at the argument about kidney allocation there are those who want better efficacy and there are those who want to maintain equity and if you're going to just use those two principles you're never going to get any place so we said okay we we like this and we're going to run with it so the way we ran with it is course equity-based because that's where we come from and we set us our first principle that we needed to maintain as demanded by NODA equitable access and equitable allocation which is really equal opportunity and what does equal opportunity do it respects the worth importance and dignity of all individuals so if you're going to have a first principle that's not a bad one to start with in terms of transplant of course that means everybody should have an equal chance of getting a transplant that's mandated by law but mathematically we could express that and we already started to do that when we were looking at the number of transplants per candidate age group but rather than letting that fluctuate we'd say what we ought to do is first principle is set that at a constant value so whether you're 65 or whether you're 20 you have an equal chance of getting a transplant and I had to include this last line because it's philosophy speak that I don't understand that that means it lexically constrains subsequent principles which might justify age mapping there's nothing about dictionaries in this so I just don't understand that so on the first principle also that helps us out I don't oh so here's the mathematical or the graph of what this would be mathematically rather than having different numbers of kidneys given to different age groups we'd start from the premise that we had to have each age group that get exactly the same number of kidneys the ratio number there is not important that just happened to be what it was in 2010 2011 is actually 0.9 because we get more people on the list and don't have any more transplants but it's across the board everybody has the same chance so the first there are the second principle we used in our step two is called prudential lifespan also philosophy speak because it has nothing to do with prudence but what it is is the principle at least applied to medicine that treating all persons the same over the lifespan is equitable not that people need to be treated the same throughout their lifespan but equal to other people at the same stage of life we do this all the time you don't get your driver's license until you're 16 we set an age at which you can vote we set an age at which you can qualify for social security might change in fact some of the previous ones have changed but but everybody's treated the same at the stage of life so this justifies giving older kidneys to older candidates now i look at this a little bit differently and again i'll use myself as an example i'm in my 60s i had good kidneys when i was in my 20s i had good kidneys when i was in my 30s and 40s and 50s thank goodness i still have good kidneys now but if i didn't what i had the same claim on a 20 year old kidney as someone who developed kidney failure at 18 and never had good kidneys when they were 20 never got that chance that i've already had and enjoyed and that to me is what prudential lifespan equity means now on the other end of this is a principle of fair innings which bob veach our collaborator championed uh you know i'm a south sider i like the white sox i know what an ending is but this this is not a baseball ending this is actually a cricket ending which i know less about but i assume everybody has to have the same number innings when you play cricket you get your fair innings but as a principal harris defines this as an equity principle that each person should be given an equal chance of a reasonable length of life and derived from that it directs health resources preferentially to those who are worst off by means of being furthest from obtaining this normal lifespan applied to kidney transplantation it's used uses being a younger candidate as proxy for medically worse off think back to the discrimination act this is sort of the phraseology they use also the same that harris used in the sense of having fewer healthy life years and less chance of reaching a normal lifespan and it justifies giving younger kidneys using younger kidneys as a proxy for better kidneys as i've shown graphically on a couple of graphs previously therefore it seems to us that it would be very consistent with the requirements of the age discrimination act so our conclusion from the ethical portion of this is that using age and allocation of these donor kidneys this is ethically permissible and does not constitute discrimination what's wrong is discriminating by limiting equal access to transplant for all patients as originally stated in nota now well comes in and summer gentry comes in because we were trying to push will to do this great continuous variable thing that everybody would proportionally listen that and he was getting frustrated with us and we actually had a conference called summer gentle gentry and she has simply said keep it simple stupid although she said it much more nicely than that and that she said you can achieve the same thing as a prototype by simply sitting up age group candidate age groups and donor age ranges and if you want to keep the proportion constant you can do that so you will have an allotment of the let's say the 18 to 34 year old kidneys the optimal kidneys and you will a lot a certain proportion of those because they're again they're disproportionate younger kidneys are disproportionately in a ratio fashion plentiful even though numerically they're not for younger donors now we didn't know how to treat the kids so we use the literature of the time that said kidneys from 0 to 10 year olds actually perform about like a 50 year old kidney so we placed them in the 50 year old pot but that's neither here nor there that can be done better and what we did is we started and we said okay we'll take all the young kidneys and our youngest candidate age group range we set it 18 to 34 because we knew those had essentially the same performance and we put a proportion of those into the youngest recipient group or a candidate group up to the quota that they would get and then those less over we put in the next group and by doing that successively we created an allotment allotment matrix which is here so if you look at the donor ages only to provide the appropriate allotment for the 18 to 34 year old only takes 30 percent of the 18 11 to 34 year old kidneys so the other 70 percent goes to the next recipient age candidate age group that pretty much fills that up 94 percent but you need some more so 6 percent out of the next age group also goes that and that fills that allotment up so most of the 35 to 49 year old kidneys actually go to the 50 to 64 age group so how does this work with this work in real time you would take a donor kidney and let's take a 20 year old as an example and that that would fit in the youngest or the optimal age range 11 to 34 and then it's allocated to a weighted probability of 29 point 29 percent going to the youngest age range and 71 percent going to the to the next youngest candidate age range and you just work that on through basically so how does that end up distributing kidneys if you look over here the answer is by mapping not matching ages you actually do very well because you give most people a kidney younger than their age so that you look at the 18 to 33 year old 18 to 34 year olds they're all going to receive kidneys from the 11 to 34 year old group and as I said if you do this on a percent basis remember there are a lot more people 50 to 64 year needing kidneys but on a percent this is totally filled up this is 94 percent filled up and you only need 4 percent of the kidneys to come from the 35 or 6 percent to come from the 35 to 49 age range on up if you look at the 50 to 64 year olds most of our kidneys are going to come from the 35 to 49 year old age range in other words still younger than I am that we put the pediatric kidneys here a few are going to get age match kidneys 50 to 59 year olds and even in the plus 65 year olds half come from 50 to 59 year old younger than they are half from 60 plus now I could go back to the graph of the age distribution of donors but most of these 60 plus are actually less than 65 because as you go over 65 they're fewer and fewer so this is actually an equitable way of giving younger kidneys to younger recipients by mapping rather than matching just look at the baseline system and its lack of efficacy because you have younger kidneys going to older recipients about a quarter of them 20 year old kidneys 30 year old kidneys you have older kidneys 50 59 year olds still going to even the younger recipients because this was a time period when we were doing the scd ecd the expanded excuse me extended criteria donors most of the older kidneys above 60 ended up with older recipients but that's a function of how kidneys are distributed currently so how did you know respond to this the office of civil rights as I said Laney and I had already stalkered our work on this but we certainly let me put it in a first person I certainly felt vindicated by the government probably the only time that I can remember I suspect she did also that they actually thought that it was as discriminatory as we did well you must respond to not by taking their hint but by saying okay we're not going to do age matching or age allocation in any form instead they devised and presented in September a new protocol which would maintain the top 20 percent into the top 20 percent by giving them preference but what it also did in which also I think is the main reason for the benefits that I'll show you is they gave the top 20 percent recipients equal access to all other kidneys now I don't think they'd want equal access to a 90 percent KDPI kidney but I think they would want access to that access to that 20 to 35 or maybe 20 to 40 percent kidney but what that does is by allowing them to double dip and this is all models by a UNOS model that is not freely available to the rest of us is it still gives a preference to younger donors in terms of the numbers of kidneys the ratio their chance of getting a kidney and I think it drives most of its benefit from that factor and not by the 20 percent into 20 percent this is a more refined picture a larger database so to speak of of looking in 2012 rather than 2011 of estimated graph survival by KDPI you can notice a couple things indeed as your KDPI index gets higher it gets lower and there's still this drop-off at the end this is one-year survival this is two-year survival and clearly there's a decrement over time which we all know that's magnified with the poor grade kidneys but if you look and they also provided us a table and I wanted to specifically compare with the question of what is a top 20 percent recipient to take if they take a 10 percent kidney it's one-year survival is 93 percent that's only one and a half percent better if they get offered a 30 percent kidney I would advise them to take it first that would be their choice and if you look even at it five years the difference between a 10 percent and a 30 percent kidney is projected to be only 4 percent now not every 10 percent kidney necessarily is better than a 30 percent kidney because they're factors that don't go into KDPI that affect graph survival that we know about but they are not that frequently involved but for example if someone had bad DIC from a gunshot wound to the head and had micro thrombi in their kidney that kidney might still qualify as a 10 percent kidney by other things but it might not be as good as a 30 percent kidney so with the overlaps here I would have no problem saying to someone you're offered a kidney that with a KDPI 30 percent you could wait and get perhaps a better one but I think you ought to take this kidney now because by waiting even someone in their 20s has a two to three percent chance of dying within the next year of complication of the renal failure so it's not without risk to wait longer here here is the outcome based on the baseline versus now their new proposal and notice that the advantage gained is cut is extensively if you look for example just lifespan lifespan benefit uh transplant versus dialysis a quarter year is all that is gained now with the new proposal so I maintain they need to go back to the drawing board once again whether they will or not I don't know and finally my conclusions age mapping doesn't raise ethical issues that still exist in the new proposal it's likely that age mapping would produce better results in the current proposal remember the current proposal only affects the top 20 percent uh not everybody and age mapping does affect everybody uh in in all the outcome measurements that they have looked at and when we presented this to the kidney transplant committee our proposal this summer and asked them to at least run it or a form of it in in their model modeling system to be able to see how much benefit it gave their response was basically they wanted to wait and see what the units board decided about their new proposal which will happen in a meeting this June so thank you very much thanks very much so um I think that to me that the crux of the argument uh and the proposal that you make is is that um the chance of getting a kidney is equal across all ages yes right um and I don't know where that lands ethically but um as I was sitting there and I was thinking okay my son is 23 or whatever four if both he and I had kidney failure and we both needed a kidney therefore I'd want him to have a higher chance of getting that kidney than me and I don't know where that lands in terms of ethics and and I suspect that it doesn't um work with the equitable things that the nota and all that stuff and the final rule set rule says but to me it just seems right that my son would get have a better chance of getting a kidney than I would would he say the same yes you don't think he's I don't believe so I believe he'd say that you ought to have an equal chance with him 20 year olds so so so I believe he ought to have a chance at a better kidney I'm not sure he should have a chance of no you you should you should you you're saying he should have equal chance of a better kidney yes and that's not only legally correct as far as I'm concerned but I also think ethically correct you're valuing his lifespan differently than you and you personalize it and it's very hard when we do with our kids but when I am talking to a 60 year old who's on dialysis not tolerating dialysis life is miserable I believe that person values whatever five or seven years he'll get out of a kidney transplant perhaps more than a 20 year old who won't take his medicines and lose it okay so that it's very hard to project our own feelings on others and I think that honestly I think people have an equal claim to getting a transplant which is exactly what notice was all about to start with but but I really I really resent the fact that we are now giving 20 year old kidneys to 65 year old recipients and and that's that's what we're trying to correct I agree that that's not right just the chance dick you showed us nota and then you showed us the final rule and the final rule said that the equitable allocation of cadaveric organs should be attitude the best use of the donated organ and you indicated that you and Laney for ethical reasons elected to go with the equitable allocation of the cadaveric organ as your starting point let's say rather than the best use of the donated organ as someone who trained for a while in England where you remember they had that informal convention never a rule never written down that organs would not go to people above the age of 55 you're showing your age mark because they no longer have that in England no I know you know it took a generation and a gradually since it was never written down it was just a matter of enough people changing the convention but maybe maybe that's it yeah but but if you start I mean if you start not with the I think the politically correct move that you made to start with equity rather than with efficiency and best use but if you start with best use which I think was behind the the English 55 rule went when they adopted it but if you start with best use could you not come up with an entirely different allocation system and then then you'd have to find the ethical justification for it but we could do that I mean we could work down on Mark I'm sure you could I guess let me give you the bottom line of my question because if I didn't know Mike was gonna ask his bottom line of my question is why don't we transplant everybody under the age of 50 before we transplant anybody above the age of well you know it's it's interesting that if you look at fair innings and don't constrain it by equal opportunity you run out of kidneys at 39 because if you say you should give it to the youngest person first because they have least chance of having a normal lifespan and you just go into your run out of kidneys at least for 2010 it was 39 I don't think anyone would say no one above 39 deserves a chance at a kidney and therefore it has to be constrained in some fashion we start with equity because I think both of us think it's important it also happens to be the law the final rule is a regulation I mean they can throw us in jail and find our hospital and other things but it actually isn't a law and I do think what they were getting at in between 1984 and 2000 was the idea that we weren't using kidneys in a prudential fashion there I used it the way it should be used Laney in other words we weren't using them in a smart fashion because it's not going to make a world of differences I showed these differences are a half year or a quarter year increased advantage over staying on dialysis incremental increase that is but that's a difference and it's especially a difference for the young person so I think our age mapping actually gets that that it actually gives young people kidneys that are equal at their age or younger and it does that for everybody so I think we actually got to a very good place we weren't sure we were going to get there when we started out add on to what Vic just said because I do love unintended consequences the other thing we have to remember is that when you look at the young people they get about seven currently they get about 75 percent of their organs from living donors whereas somebody over 40 has about a 25 percent chance of getting a living donor and I mentioned that because if you gave all the deceased owners to those under 39 two things either happened one nobody serves as a living donor because their loved ones got the kidney they wanted or we're going to start having the 30 year olds giving to the 60 year olds and living kidneys are even better than even the best deceased on the kidney and so if you want to talk about an inefficient system is to increase the number of living donors going to older people so you need to have some way of still encouraging the young person for seeking out a living donor otherwise you're going to decrease the whole pot and remember you know only gets to control 60 percent of that high because they don't control the living donors I would argue a little bit against Laney it's that the benefit level given here is not enough to convince anybody to wait to get a deceased donor kidney if they have a living donor and like Mike most most fairings would but moments proposing that except it's a straw thing to knock down I think Mike's question says what's going to happen with the 20 year olds is those of us that are still healthy enough to give our kidneys to them will right so it's already 10 plus after the after the hour and so obviously a very interesting and controversial area that still hasn't been solved congratulate dick and Laney for trying to to get something better and thank you dick very much for presenting