"And once I gave a report to the Kidney Foundation, I guess about 1969, and it was run, in those days, by senior scientists. And one of them said to me, 'You people just went ahead and started dialysis without really understanding it. You didn’t know how to measure it; you didn’t know what you were doing. You just did it. That’s unscientific.' And I said, 'I have to admit you’re right. But the one thing we did know was that if we did it, the patients lived, and if we didn’t, they died.' How could we not?"
Dr. John H. Sadler served on the faculty of and led the Division of Nephrology at the University of Maryland in Baltimore while directing major clinical, dialysis, and research efforts for over four decades. A native of South Carolina, he attended college and medical school at Duke University, then moved to Atlanta for residency and fellowship training at Grady Memorial Hospital. An early proponent of kidney transplantation and organ sharing, he was President of the South-Eastern Organ Procurement Foundation (SEOPF, which gave birth to UNOS) and collaborated on many studies concerning patient care and survival with various renal replacement modalities. He participated in the Institute of Medicine ESRD Program Study with its 1991 report “Kidney Failure and the Federal Government,” and in 1993 led the Life Options Rehabilitation Advisory Council with its program to optimize life-time care for end-stage renal failure patients. He was a founding member and the inaugural President of the Renal Physicians’ Association and has won many awards, including the American Association of Kidney Patients Medal of Excellence. Now retired from the University of Maryland School of Medicine, Dr. Sadler is the President and CEO of the Independent Dialysis Foundation, a not-for-profit dialysis provider in Baltimore.
Dr. Sadler: I’m John Sadler, I’m a nephrologist. I spent most of my career at the University of Maryland in Baltimore after beginning my career at Grady Hospital and Emory University in Atlanta. In between, I spent a year in Richmond, and I’ve been involved with transplant issues since the late ’60s.
Interviewer: How did you become interested in kidney transplantation?
Dr. Sadler: As a practicing nephrologist, I got interested in what we could do about people who had progressive kidney disease. So I’m a two-handed nephrologist; I was working in dialysis and I wanted to work in transplant. In those days, we didn’t know a great deal about transplantation. There were a few people in Boston who were transplanting twins, and the rest of us were sort of listening at a distance and trying to figure out what to do.
I mean Paul Terasaki in California, Bernard Amos at Duke, and a few people in Europe were trying to figure out matching and this kind of thing. But the way to get organs and give them to people who needed them was still in its infancy. In 1969, the Southeastern Organ Procurement Foundation was organized as a consortium to see if sharing organs would improve transplantation and allow us to learn more. I was in Atlanta at the time and we had no transplant program. But we had an extremely active emergency service, which had the potential to provide cadaver donors for transplantation.
We didn’t have brain death legislation then; we had to do this all on cardiac death. And I would go and interview families. When we got consent, I would follow the patient to the operating room. When one of the surgeons took out the organs, I would be on the back table, cleaning them up and cooling them down.
So I started with my hands in this, doing these things. And then, of course, we sent out every organ we retrieved because we couldn’t transplant them. But as time went on, we got a transplant program going and the Southeastern Organ Procurement Foundation, SEOPF, became a partnership of colleagues who had great confidence in each other, and that confidence allowed us to try things that we wouldn’t have tried if we didn’t have that confidence.
And through that, I think that we really built more knowledge of tissue typing and more knowledge of organ management and systems of organ sharing that were fundamental to what we do today. And I was only a very small part of that, but I’m very proud of having had something to do with it.
Interviewer: Let’s go to your days in Richmond and some of the players and what you did in Richmond.
Dr. Sadler: Okay, well when I decided that room to move ahead would have to be somewhere else, I talked to Dave Hume and he encouraged me to come to Richmond. I talked to some of the internists and nephrologists there and I came in. And Dave was very gracious and very welcoming, and I admired him so much because he was one of the few people who really had done some transplants, had thought about them, and was just promoting the practice as much as he could.
And so I felt that Dave had never had strong nephrology support since he had come to Richmond and I wanted to give him that. And so I came to Richmond and I brought some people with me who were active in the organ procurement part of the program, and I worked with H. M. Lee more than anyone else, and things went pretty well for us. But I learned after a while, that you don’t work with Dave Hume, you work for Dave Hume. (Laughs)
And when I got a very attractive offer from the University of Maryland, I moved to Baltimore in 1972. I had come to Richmond in 1971.
Interviewer: Um, talk a little bit about some of the surgeons that were in Richmond that you worked with. If you could mention some of the early names that you worked with?
Dr. Sadler: Well as I said, Dave Hume, H. M. Lee, Mel Williams, and Sil Sterioff who were with the team at UVA. And there was a small program at Georgetown. There was a miniscule program at the University of Maryland, we had to build one and things were just getting started, and Randy Bollinger was at Duke building their program, which was also just getting going. And most of the programs were pretty small.
I think aside from Hume and Lee and Mel Williams, the people were all growing into it. And we were all learning together. I mean I think that Mel and I, when I came to Baltimore, used to go around and make presentations to medical groups and interested parties. And I think that worked fairly well and the programs in Baltimore grew.
You know, when I came there, I was managing the organ procurement activities. And I did that for, I guess, about five years. And then I turned it over to another team and we moved it outside the medical centers.
Interviewer: You had mentioned when we were off camera the learning on your own, the chap from the Kidney Foundation, that was a neat little story.
Dr. Sadler: Well I think that all of this time, we were learning as we went. Every day we did something we’d never done before, because we were trying new things and trying to be successful. And of course, as I say, I was doing dialysis and transplantation work.
And once I gave a report to the Kidney Foundation I guess about 1969 and it was run, in those days, by senior scientists. And one of them said to me, “You people just went ahead and started dialysis without really understanding it. You didn’t know how to measure it; you didn’t know what you were doing. You just did it. That’s unscientific.” And I said, “I have to admit you’re right. But the one thing we did know was that if we did it, the patients lived, and if we didn’t, they died.” How could we not?
Interviewer: Tell us a little bit about some of the clinical circumstances that you had to deal with as a young transplant nephrologist. They were so different then, acute rejection, severe infection, blown anastomoses and so on. You lived that, I did as well as a resident.
Dr. Sadler: Well when we started, it was still a time when you really expected perhaps 50% one-year success. And you really expected that 80%, or more, of patients would have an acute rejection episode before they left the hospital. And all we could do was treat them with high-dose steroids at first, and then we learned to try other agents.
Most of the time the acute rejection was suppressed and the patient went on. But a significant number of them were lost; I would say probably 10 to 12%. And then we watched rather fearfully for what else might happen as time went on and tried to find ways to do it. I mean it was azathioprine and prednisone that was it. And so we gave more and more prednisone when things got bad, and that was not particularly good for patients.
Interviewer: Tell us a little bit about the genesis of SEOPF and go from the SEROP to the SEOPF to the AFDT.
Dr. Sadler: Well the origin of the whole thing was a grant to try to demonstrate that organ sharing would improve transplantation; that was in about 1968. And so a grant was made to the institutions in North Carolina, Virginia, and Maryland as the Southeastern Regional Organ Procurement Grant.
At the same time, because we had no transplant program in Atlanta, but a big emergency service, we were given a separate, related grant to try to be a supplier of organs to the group. And that worked fairly well, and the next time the grant was renewed, we were brought in as a member of the overall consortium, under a single grant.
And when the grant expired, which I believe was in about 1970 or ’71, we decided to form the Southeastern Organ Procurement Foundation and carry on, without the federal money. And that’s what we did, and it had a life of its own. And it was, I think, the most successful organ sharing program in this country at the beginning and probably in the world.
As we went forward, there was some resistance and reluctance of transplant programs that were not part of SEOPF. And we were a little uneasy about expanding SEOPF, because the confidence we had in each other, and the knowledge we had of each other, made it easy for the program to work, but we gradually expanded. And then I believe in 1974, Gene Pierce, the Executive Director, said “You know, we really ought to make this registry available to everyone.” Fred Westervelt, who was the second President of SEOPF, (and I was the President-Elect) said, “Well, how are we going to pay for this?”
And after a while, we agreed that this new registry would cost people only the computer time it took to do the registry for them, and they pay their own share of that, and we give them the rest of it. And it went forward and it grew and did very well. And then, of course, it became UNOS. And UNOS became the registry, the organ sharing facilitator, and the Southeastern Organ Procurement Foundation became the American Foundation for Donation and Transplantation. That was a difficult transition because SEOPF, having given UNOS its principal function and its source of income, had to re-define itself.
Interviewer: Tell us some memorable moments.
Dr. Sadler: (Laughs) How much time do you have? You know, there have been lots of memorable moments and they have happened wherever I have been. And you know, I think that they really are almost too numerous to mention. But we had moments when you’d go back to SEOPF where we would have strong differences within the organization, but they never interfered with our collaboration.
I told you I had directed the organ procurement activities at Emory and I had done it again when I came to Maryland. And we were very reluctant to use plasma to perfuse the kidneys. We were reluctant to use plasma protein fraction and we found an albumin preparation that worked. And we used that for a while, it came from Sweden.
And when we could no longer get that, we tried American albumin solutions, and we killed kidneys all over the place. And we lost a couple of patients because we killed those kidneys. You know, that’s how you learn hard lessons, and it always cost the patients more than it cost us.
Interviewer: Say a word or two about the development of the discipline in the absence of institutional review boards.
Dr. Sadler: Well you know, had there been an FDA-oversight institution or review boards, we’d probably still be where we were in 1970, because it was that free-hand exploration in the face of small amounts of information that allowed us to go forward. Now we took risks and our patients sometimes suffered from those risks. But we made a great deal of progress.
You remember when Fred Belzer designed his perfusion machine, because at that time, we were rinsing kidneys with extracellular solutions and they didn’t survive very well that way. And his machine did a better job, but it was large and cumbersome.
And the Waters people developed a smaller machine with a nice, compact cassette which could be sterilized and used again. And I remember going to Minnesota to learn about that machine. And we saw it, we liked it, and we brought it back and we used it for several years. And then, of course, they developed their intracellular solutions for preservation and perfusion more or less disappeared.
Interviewer: I think that it would be valuable for you to describe certain clinical circumstances that patients faced. Most of them were in the hospital for prolonged periods in those times. The bleeding, I mean dialysis wasn’t as good, so platelet function wasn’t as good, and so on and so forth. And I think younger professionals don’t have an appreciation for that.
Dr. Sadler: Okay. Well we have to start in the ’60s and ’70s by saying everything we did was a scare resource. There was not enough to go around.
When I started doing dialysis, we really did have death committees. And only about 25% to 30% of the people we reviewed were allowed to come onto dialysis, because they had a support system and other good health so they could survive. But there wasn’t enough dialysis; even after the beginnings of Medicare support for ESRD, there wasn’t enough dialysis.
And the rule was that if you got a cadaver kidney and the kidney failed, your place in dialysis was gone, and so were you. And you know, that was a terrifically painful thing to say. The patients knew it; we told them directly that if you want to do the transplant, we’re going to do the transplant. We think you have a 50% to 60% chance of success. But if it fails, you have failed and we’ll take care of you the best we can, but we don’t have room for you in dialysis.
That was among the most painful things I ever did, because obviously you have a number of patients whose kidney does fail and you have to just comfort the patient and let them go. We lost a lot of patients because we didn’t have the capacity to take care of them. And it was very stressful, but I think I learned a lot about my own humanity and theirs. And I think that it made me better able to take care of patients since then, when we have the resources. And I think it taught me that you have to be a good communicator, because these patients are taking high-risk steps and they need to understand what they are doing as well as they can.
Interviewer: Let’s talk a little bit about “It started as the American Transplant Physicians,” certainly mentioning the Kidney Foundation or other organizations. These organizations had a role, and particularly with the Kidney Foundation, it had a principal role in the Medicare legislation, I think.
Dr. Sadler: They played a large role in that. Now in the late ’60s, the National Kidney Foundation was the only national organization interested in kidney disease. It wasn’t really very national, it was largely northeast, with a few scattered affiliates in other places. But they were at least organized and trying very hard to promote information and progress for kidney disease.
They were also trying to control everything that developed, so it would all be under the umbrella of the Kidney Foundation. And I worked with them because I needed them and they needed me, because we had to make progress together. And I worked on their original dialysis and transplant committee, which mostly was just talking about what we knew and didn’t know and unable to really go much beyond that.
I helped them get an affiliate started in Georgia, and I worked with them on lobbying the Congress. We tried for several years in the mid-’60s to define how we were going to pay for this. You know, when I had a dialysis grant, I was told, “If you don’t find a way to pay for it when the grant ends, we’re not going to give you the second year of the grant,” so we had to be creative.
You went to philanthropic organizations and asked for donations. You went to state agencies and asked for vocational rehab support. You went to insurance companies and said, “There are only 44 people per million per year coming into this. If any of them happen to be covered by your insurance, won’t you pay for this?” And most of them thought, “Well it’s not very many, and it’s not very much, we could do that.” So we got little bits of coverage.
And then it struck us that if these people had Medicare benefits, they would have secure coverage and it would be widespread. So that idea was something that grew. And we began going to Washington and talking to the Congress about it.
The Kidney Foundation had a lobbyist who was there all the time, I think he had a few other clients, too, but he was mostly for the Kidney Foundation. And I was going up, John Bower was going up. Other people were coming in from other places.
But you know what really made the difference, I think, was that Senator Vance Hartke, who was not heavily involved in health legislation, became convinced that that was the right way to go. And so he inserted a line in the paragraph of the Public Law 92062 in 1972 that said that people who are disabled for two years would then be eligible for Medicare benefits. And he put in a line saying, “Those who have end-stage renal disease will after three months be deemed to be disabled and be eligible.”
It went through the conference committee, I think, sort of under the radar and the bill was passed. And then the Medicare people found out in December that this had been passed in November, and they had no clue as to what end-stage renal disease was, what it cost, how it was treated, and they were obligated to produce a policy for the federal government by July of 1973. Those people were—well first they were angry and then they were frustrated.
They went to Seattle and talked to Scribner and Blagg. They went to Richmond and talked to Dave Hume. They went to Hopkins and talked to Mel Williams and they came and talked to me, because I was the closest dialysis and they could learn about what to do.
They produced a set of regulations that looked like they had been produced by people who didn’t know what they were talking about. Because they didn’t. But they had done a manful job of trying to learn. And between June when they released their proposed rules and late October when they revised them and put them back together, they became something that we could work with, even though we had lots of differences with them. And so the feds have been trying to help us and control us ever since.
Interviewer: I really want to hear you talk about some specific complications that you remember that occurred in the early days that we don’t see now, the rapidity of acute rejection, the bleeding complications, the dialysis difficulties, just three or four things from your memory that were commonplace for us then. I mean I know some young transplant surgeons who have never seen an accelerated acute rejection let alone a hyper-acute rejection.
Dr. Sadler: Well you know the hyperacute rejection was one of the most ghastly things I ever saw. You put the kidney in, you get the anastomosis complete, you open the clamps and the kidney swells and turns purple and dies, right there before you. I only saw that about twice, but it is a memory I will never, ever get over.
And then the people who had the accelerated rejection, you didn’t see it when you were closing the wound, but they just didn’t pee. They just didn’t do anything. And we would treat them and treat them and treat them and sometimes one would come through, but most of them failed.
I remember we had a meeting in Richmond and Dr. Hume asked me to make a presentation about the care of the transplant patient from the nephrologists’ point of view. And I went back and reviewed our records for the previous two years and I came forward and I said, “Dave, do you realize that if a patient has to be dialyzed after a transplant, his odds of keeping that kidney are less than 30%?”
He said “I don’t believe that.” So I showed him the data and he said, “Well what are you doing bad? What are you doing wrong?” (Laughs) I said, “I don’t think that dialysis kills the kidney. I think it’s the fact that they need dialysis that says the kidney is not going to work.” But he really was upset with me. He let me give the presentation, but he gave a rebuttal afterwards. But it was really true that if your kidney didn’t work well enough to keep you off dialysis to start with, the odds of it coming around were very small.
Now if you got through and made urine and then had an acute rejection, you might need dialysis a few times before that was corrected. That had a lesser ill effect.
But you know, those things were horrifying and I will say, without naming names, we had a frightening number of vascular disruptions. And when you go in and see that bulging wound, you know that something’s in there that’s not supposed to be there. And a renal-iliac anastomosis or a renal-femoral anastomosis bleeds very rapidly and it usually couldn’t tamponade itself, because the skin would just keep stretching.
And we had infections because we were using a lot of steroids. And sometimes the only way to get rid of the infection was to stop the steroids, and sacrifice the kidney.
Interviewer: What little message about the history of transplantation do you want to say that we haven’t covered?
Dr. Sadler: I think that we’ve covered a lot of it and I think I have tried to give you a flavor of how we were learning as we went along. We were collaborating as real partners across institutions, which is hard to do. But we did, I think, very well. And I think we began to share information nationally and internationally and that helped. And I think the pioneers like Paul Terasaki and David and Bernard Amos who were collecting sera and trying to ascertain what they meant and what they did gave us a foundation for doing things.
And when I look at transplantation today, with all of the modern drugs we have, and the success that comes largely through those drugs being able to overwhelm incompatibilities, I am very gratified. And I am pleased that we have learned to do live donor transplants without harming the live donor quite so much, and I am hopeful that will be a significant advance.
But it is still a field in which we have far to go. We don’t have enough kidneys. We have too many patients. We don’t prevent the diseases that cause renal failure. You know, with what we know, if we were to start early enough, hypertension, which is 30% of them, diabetes, which is 45% of them, wouldn’t necessarily progress and we’d cut it down. So if we don’t learn to prevent this, it’s going to be much more complicated to refine the practices we’d use to correct it.
Interviewer: Say a word or two about the SEOPF database and the papers out of SEOPF, you were on a number of them. And then also the ASTS.
Dr. Sadler: Okay. We, SEOPF, progressively developed a more successful, automated database of information about patients. As the registry went forward, there was a great deal of rich data and we began to publish about those data and what we knew that helped us to improve immune-matching. It helped us to improve organ sharing; it helped us to improve transplant techniques because we could relate success and failure to every factor. And we had almost everything in there, because we got follow-up data on the patients after transplant, which was so critically important.
And when it became clear that we needed more organizations to promote information, learning, publications in the field, the American Society of Nephrology was doing some, but it wasn’t their focus. We had several regional nephrology organizations that were not getting it done. And so the ASTS was formed, the ASTP was formed, the American Society of Transplant Surgeons and Physicians.
And I must confess, I was put off because it took two societies to contain us. I really thought that was a weakness. And yet as time has gone on, obviously the collaborations have come back and it works well. It’s necessary to have societies that promote learning and research and information sharing, if you are going to advance any field. And that’s very important and that’s being done.
Interviewer: Where do you think we will be fifty years from now?
Dr. Sadler: In fifty years, it’s far enough out that it’s sheer speculation. But I have little enough confidence in the process of producing xenografts from pigs or sheep or other organs that I don’t believe that’s going to work.
I have hope that maybe in fifty years maybe we’ll learn how to grow organs from stem cells. We know now that we can grow vessels, we can grow intestine, we can grow other things from stem cells. I gather that they can make islet cells out of them, but we haven’t got it to human use. And I think we can convince stem cells to make kidneys, in fifty years.
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