 So I'm going to start this afternoon session. I'm Laney Ross for those who don't remember me or we're here before I arrived 23 years ago I always thought I needed a passport to live in Chicago mark, so I don't have to move anywhere But anyway, the session this afternoon is on transplantation ethics and part of the reason for that is that this is the 50th anniversary Not only of Henry Beecher's ethics and clinical research, which has been celebrated this whole year But actually in March of 1966 there was a Siba Foundation meeting in London it was an international meeting as I'll be talking about and It was the first meeting on ethics and transplantation think about it only about 500 transplants had actually been done at the time and already they were worrying about all the ethical and policy Controversies that were rising from living donor as well as deceased owner transplantation So that's what my talk is going to be about and then we're going to talk about lots of other Ethical and policy issues in transplantation for the first session of this afternoon. So let me begin with my talk Anybody who wants to read a bio you can get it from The students over here so 50 years ago as I said the Siba Foundation had this meeting and I want to look at their ethical issues So in 1966 at this meeting the main ethical and legal issues that were raised with regards to deceased owner kidney transplantation Focused on quote how to define death and one of the surgeons from Edinburgh Dr. Woodruff commented that we really need a conference of a slightly different composition to consider this business of what is death and Actually that conference takes place two years later. So two years from now at the 30th McLean Conference we could actually talk about that very important article the ad hoc committee of the Harvard Medical School when they wrote the Paper a definition of irreversible coma, but that wasn't going to be what this meeting was focused on They didn't have the right people there Instead what they were worried about with regards to death versus dying was that there were lack of rules regarding the timing of When to procure organs, right? So now when we declare someone dead if we do it by circulatory There's a question of how long do you have to wait type of thing those questions weren't yet being raised? And so the whole question of could you take organs from dying but not dead individuals was still up for grabs and actually Dr. Gea Alexandra from Belgium Described the practice of removing kidneys from eminently dying patients He approved of the process and this is what he said in the Siba meeting he wrote in our nine cases We switched off the respirator immediately after the kidneys were removed the heart beats of all the patients cease within two to three minutes In my opinion it is irrelevant whether a heart-lung preparation goes on for two days or even for weeks It's still a heart-lung preparation and for us. It is still a dead person in Contrast Keith Rimsma a surgeon from New Orleans He argued against taking organs from people who were dying and not yet declared dead and this is what he stated at Present it would not be acceptable in many countries to remove vital organs from living persons prior to what we now accept as death We would do better to use our energies to make available the tissues of recently dead people This is going to be our major source in the near future And as we all know Rimsma positions prevails and today organs are only procured after the donor is declared dead Which is colloquially known as the dead donor rule and although it prevails Globally, they're actually it's being challenged on both sides. Some view it is too permissive Because they don't agree that we're actually when we use whole brain criteria that we're actually not testing for all brain functions And some view it is too stringent and want to argue that it really is irrelevant Whether you have a corneal reflex to be declared dead and things of that sort So but Rimsma's prediction that deceased donor kidney transplant would be the main source of kidneys actually holds globally with some exceptions And so again, he was right But yet there is no international consensus It wasn't then and it still isn't on how to define brain death Let alone how to measure it and there's no consensus as I've mentioned on the appropriate time interval after Cardiocirculatory death The conference mainly focused on living donor kidney transplant and part of the reason for that was that was where really most of the Success was happening and here were the seven issues that they raised and these are the seven issues that I want to spend the Rest of the time talking about so looking at the first point Is it ethical to maim an individual for the benefit of another and I chose this language because that's the language that was used at the Siba Conference so and the answer was twofold one is it could be ethical to maim an individual with Consent and the second point was and this is a very important one They viewed living donor kidney transplant as a temporary solution So with regards to consent Joseph Murray the surgeon from Boston who had performed the first successful living donor kidney transplant between Identical twins in 1956 he acknowledged we make a basic qualitative shift in our aims when we risk the health of a well person No matter how pure our motives But because of this shift he and others place great emphasis that the donor give a voluntary and informed consent But he's also known because he basically said And warned about doing surgery on healthy people for the benefit of other people and he said all clinicians working with kidney Transplantation should strive for better deceased donor organ procurement so that the day will come when even the identical twin will not require a living donor Boy has that changed in 2016 there's much greater accepting of living donation We now view it as a long-term solution. We've moved from identical twins to extended family to friends to strangers We've moved from directed donation where I give directly to a family member to being involved in parrot exchanges and chains We've moved from living donor kidney transplant as a possible solution to really the preferred option including now as we talk about it there are Programs like donor champions coaching individuals on how to ask and encouraging the use of social media to find people who might Be willing to donate your organs some of which may have some ethical Controversies with using it So how then did would Murray and and how today would we ensure that consent is voluntary and informed so back as I said in 66 this was a major concern and so for example Woodruff in Edinburgh said they never accept the yes at our first discussion I think that approach provides adequate safeguards against coercion So they basically were saying that if they gave the information and they and they sought out consent You couldn't just say yes doesn't mean yes yet to say yes. Yes in order to be a living donor I'm bourgeois a surgeon in Paris Had a psychiatrist joined the transplant team to determine whether the desire of the donor is stable well-balanced and rationally motivated and Then to also uncover any possible pressure coming from the other members of the family So really very very concerned that people were acting voluntarily and free of coercion in 2016 we've formalized it we now require living donor advocates and social work evaluations for all living donors Broadly adopted to evaluate whether there is undue pressure or inducements and to determine their consent is informed and voluntary Some programs require a psychiatric Involvement as well others only use that depending on the potential donor But the concern now becomes really magnified because as we've moved away from direct donations to allowing Chains and exchanges we've taken away one of the main reasons why individuals were Rejected in earlier years, which was an ABO incompatibility now It used to be when you would go in and you would get tested if you were ABO incompatible You were basically told you're not Eligible to be a donor and that was it and while some people were disappointed There were some people who were probably quite relieved now. No one gets that medical excuse in that sense I mean we can talk about whether doctors should be giving out medical excuses But now there is no longer that excuse because even if you can't donate directly to your sister you can get involved in a chain or an exchange The identical twin is an interesting one. Remember Murray's quote that He's looking forward to the day when even the identical twin won't be asked because back in 1966 we really didn't have any immunosuppression other than steroids and so Basically, it was only the identical twins where we had really good long-term outcomes And so this concern of the of what role the identical twin should play Sir Robert Platt a British physician explains It's the only situation in which the operation is really likely to be a lasting success Secondly, there is it has been said only one donor. In other words, it's not like we can go to the whole family It's only the identical twin who was really the eligible individual to donate and so the onus or pressure is much on him Thirdly identical twins often have a great very great understanding between each other which might make the volunteering more easy Or more difficult so a lot of concerns about the the potential Coercive nature of being an identical twin There was also a concern expressed in 1966 was whether the identical twin may actually be an increased risk of developing end-stage renal disease Themselves right because to whatever extent this is genetic They have the same genes as the donor it does as the recipient and what's interesting is that in 2016? We still don't have evidence about whether an identical twin is at increased risk of developing end-stage renal disease If his or her twin has end-stage renal disease And we don't know if this risk might be increased by doing the nephrectomy. Is that sort of the double-hit hypothesis? and part of the reason the evidence is lacking is because we don't keep a Universal registry right now in the u.s. We now are mandated to follow up for two years We only started doing any follow-up in the late 1990s and so we really don't have the data in park if we've never looked The next issue was the issue of minors as donors and here there was a lot of controversy back in 1966 so should individuals who are under the age of 18 or 21 in most locations in 1966 be allowed to be living donors and Against it was a French surgeon who based as well as a British legal scholar David Dowby who wrote children should on no account be donors And there should be no cheating by maintaining for example that the child would suffer a trauma if he were not allowed to give his Twin a kidney or whatever it might be the likelihood of a trauma Incidentally will be greatly lessened if the law leaves not the shadow of a doubt that a transplant is here out of the question The case will then be no different from where a twin dies from pneumonia bad enough But with no scope for offer of a sacrifice disappointment or self-torture in contrast Murray was willing to allow twins as young as 12 or 13 as well as argued in favor of allowing Adolescent identical twins because of both the high likelihood of success and because as Dowby predicted the trauma if the healthy one did not offer a kidney at the age of 15 say in 2016 the guidelines vary an international systematic review found that 27 of 39 guidelines endorse an absolute Prohibition of living kidney donation by minors, but 12 guidelines allowed it under certain conditions So for example would exceptionally allow living kidney donation by minors provided that adequate safeguards are put in place Including an assessment of the minors autonomy and maturity Authorization by an independent body like a living donor advocate program Assuring that the anticipated psychosocial benefits outweigh the medical and psychosocial risks for the donor and the restriction to situations of last resort The the data from you knows shows that twins have actually served as living donors, although it is rather Uncommon here in the United States The next issue was health risks So back in 1966 while some attendees worried about whether living twin donors would increase risk Most weren't concerned about the risks of taking out a kidney So good when a urologist from California was adamant that quote the removal of a kidney has been described as a terrible thing But it's not so serious as has been made out in the conference and Woodruff from Edinburgh claimed to be without a kidney In most cases is no disability Certainly much less for example than being without a big toe if the other kidney is all right Although he did then concede later on in the program that there was a small perioperative risk And boy has that changed recently While then at that time no other health risks were discussed in 2016 in the last five years They've been numerous papers that have come out to show one what we already know about the perioperative risk But now we're aware of some long-term risks including an increased risk of developing end-stage renal disease pregnancy complications and women who have been donors and cardiovascular problems such as hypertension as I've already mentioned though no data about identical twins and what the risk of a unilateral nephrectomy And so one of my main points is we really need a systematic global long-term follow-up Program in order to really understand what we're asking of people when they ask them to serve as a living donor My last slide will be about the economics and here There were there were really two issues that were raised at the SIVA meeting One was about the barriers the financial barriers, but also the ethics of Of an organ market so with regards to the economic barriers They talked about both insurance and out-of-pocket expenses in 1966 and with regard to insurance Murray cited data that insurance companies would not discriminate against donors He called a couple of insurance companies and they said it they're found healthy Then it wouldn't matter whether they had one or two kidneys in 1966 the out-of-pocket expenses Shriner an internist in Washington DC stated somebody going in for his own medical care It might be willing to handle these out-of-pocket expenses But the volunteer has gone further in a sense We have a higher obligation to him and in fact in Britain people like brotherston raised the issue of paying for the Consequences to the donor of giving the organ they may have heavy travel charges He may suffer loss of earnings and there may be other financial implications so again 50 years ago They understood these issues today. There's some data to suggest that donors do have difficulty getting insurance Whether this persists with Obamacare has not been studied and of course whether Obamacare remains We also don't know In 2016 out of expense out-of-pocket expenses the study showed to be quite significant And there is broad support for removing these financial obstacles to living donation But uniform and universal methods to cover these expenses have not been established The issue of markets just given the limited time. I'm just going to say that this broad I'll be at non-universal consensus against organ markets both then and now So to conclude 50 years ago organ transplant has become well established throughout the world However, many of the concerns raised at the seba symposium remain highly relevant and arguments similar to those made by the attendees Continue to be part of the current debates These debates have helped to shape the current ethical boundaries of organ transplant Riesma summed it up. Nicely He wrote the experience cited at this meeting illustrates that medical science has influenced ethics just as ethics has influenced medical science In the next 50 years the ethical considerations must not lag behind the scientific advances in transplant But instead must keep pace with if not proactively predict them This will best be achieved by transparency and innovative developments and the inclusion and engagement of individuals from a broad range of Disciplines in designing research protocols and developing policy and practice guidelines. Thank you very much myself five minutes for questions please Very interesting. I envy going through those papers. I must have been fan fascinating In 1966 even more than today it would have been unusual For people from a variety of different cultures to get together in one room Obviously preskype that kind of thing. I'm curious when you looked through the notes I mean obviously medicine in general is social and contextual and particularly organ transplantation and Particularly the words that are tossed around words like consent and minor and that sort of thing Do you see national styles? Do you see people behaving differently from different? Social contexts, or do you see a desire to act as though everybody means the same thing when they use those words So it's less archival than you had hoped they actually publish the symposium into a book That's actually now available online. So I'm not actually looking at the original Information so this is what has been already cleaned up type of thing What's interesting? You say, you know a diverse group of people in the audience. It was all male It was all white. It was from the US and Europe, but from nowhere else So not as diverse as we would hope in 2016 when the conversation comes It also included, you know doctors and one theologian one journalist and lawyers, but there were no philosophers religious ethicists patients Either candid recipients or donors and and things of that sort Hi, Laney. I might shapero Rutgers Lady, you know, obviously there's been a great deal of quote progress on quote in the science of Transplantation in the last 50 years. You've shown us the difference In some of the ethical policies. I wonder if you could comment on whether you think that's progress or not Well, so again, I think that the answer to that is partially contextual in that So I do think the science is changing and as the science change we sometimes have to rethink where our ethics are I think some of the debates though are really are pointing out where our science is missing Right. I mean the fact that we don't know 50 years later whether we're putting identical twins at greater risks and other People is really shameful and the fact that it took us 50 years to understand about some of the risks of Increased risk of renal disease and heart disease was because so there's a famous book called the gift of life Which was written by Simmons and Simmons He was a transplant surgeon. She was a social worker and it's divided into three parts It was divided into donors non donors and patients So the recipients of organs were considered patients But the donors weren't and I think that's been one of our biggest scientific Misses in the whole field was that we haven't considered until very recently the living donor as a patient Which is shocking because you're taking this person to the operating room and yet So I think that the science actually Has missed the opportunity to to allow the ethics to go along with it Okay, well, thank you very much