 Michael, of course, is an expert in adult and pediatric transplant surgery. His clinical interests include liver transplantation, hepatobiliary surgery. He's performed more liver transplants than any other surgeon in the region. His research explores the application of cellular technology to patient care and health and policy ethics. He's a consultant to the Chinese Ministry of Health to help them transform their transplant system, including the development of a donor system for volunteer citizen deceased donors. And let me then just ask Michael to come and address us on organ transplant in China. Michael, thank you very much for coming. Thank you. Appreciate it. Peter, thank you very much for that great introduction. I'd like to thank Mark for inviting me to give a talk, as well as working with him through the faculty series this year and obviously the McLean family for supporting all of this and much more from the university. This is my conflict of interest slide. I don't think I have any conflict of interests, but ultimately that's for you guys to decide. My work is supported by a grant from the China Medical Board, and it is to improve the practice and policy of transplantation in China. It was initially funded in 2007 and refunded in 2011. As a surgeon, I'm frequently asked when I tell them that I do work in China and I'm a transplant surgeon, the most common response is, oh, do you go over there and do transplants? So I write off the bat, I'll tell you that no, I do not. And once again, I thank Peter for really helping define exactly what I am doing there. My goal is not to go over and do a transplant, not really to teach them how to do transplants, but to revolutionize the transplant practice in China. And so from that paradigm is really from which I work and try to improve things in China. So what are the ethical issues that focus our attention in transplantation in China? And I've divided these for the fellows into the typical clinical medical ethics paradigm of non-maleficence, beneficence, autonomy, and justice. And you can see that there are many issues that confront us in terms of how to ethically look at the transplant practice in China. The top left or top right picture there is of Zhai Fu Huang, who is the Vice Minister of Health, at least as of right now. As many of you know, China is currently undergoing its week-long transition of power that they do every decade and one really doesn't know at the end of the week what positions that the current people have or what new people will have in the future. So as of right now, as far as I know, he is still Vice Minister of Health. It was my understanding that he is friends with the presumed new leader of China, so hopefully he will still have a leading position in healthcare in China as he has truly been a very committed person that has been able to institute change with the transplant policies in China. And so in 2006 at this WHO conference was the first time that it was admitted by any Chinese official that they indeed used executed prisoners as their donor source. And following that scientific article in 2007 also confirmed that practice. So of course the press focused on the organs from executed prisoners, a reasonable focus. However there were many other problems, ethical problems, in regards to their transplant programs in China that dealt with quality, lack of a database, lack of transparency at every level, transplant tourism and payment of organs. So we'll get the first group out of the way right off the bat. I and the leaders of China that I work with, Jifu Huang and others, feel that the utilization of executed prisoners is not consistent with what they want to have the transplant industry and business in the future and understand that it violates human rights because death row inmates may feel oppressed to become a donor. And this is a slide from Jifu Huang. So this is not a slide that I've interpreted as their feelings. This is indeed how Jifu and the leadership of China feels. They also agree that commercialization of transplant services is unethical and that they recognize that in the period of time, certainly before 2007, it was rampant in the terms of transplant tourism and payment of organs for organs. And they understand that that violates the principle of equity and the goal of establishing a harmonious society. Once again, a slide from Jifu truly indicating that that's what they believe. Let's go back to 2006 and examine exactly where transplantation was in China. Greater than 95% of the donors were from executed prisoners. Transplant tourism with payment of organs was widespread. It was somewhat stimulated by a legal system that encouraged compensation to the agreed party accounting for at least 50% of the kidney transplants and 60% of the liver transplants performed in China at that time. Over 600 hospitals were performing solid organ transplants and this was really stimulated by the fact that during this period of time government payments to hospitals in an attempt to try to increase the market for healthcare was decreasing their reimbursement to hospitals and hospitals found that what they thought was a reasonable way to increase their revenues was to market transplant tourism. Our Kaplan mentioned that there are websites and there are still some out there today that you can Google and say come and get your transplant pay obviously and it helps the revenues of those hospitals and that there were no regulations governing transplant quality throughout the whole country. So the first thing that Jifu did was call a meeting of all the transplant centers all 600 plus of them to a meeting in Guangzhou and said okay similar to actually what was happening in the US at that time and that was with the CMS approval for transplant programs everyone will have to reapply for the US and CMS was making all programs that currently had CMS approval reapply in China since there was no regulation there was no approval from the Ministry of Health it was all the programs had to apply to be able to subsequently continue to perform transplants and they outlined the criteria in which each of the applications would be assessed experience of the surgeon, volume center, institutional support and field strength and that in the first step to try to reform the executed prisoner aspect that they recognize that the prisoners and the prisoners family must sign consent. So the four principal areas of focus were to regulate quality to regulate transplantable organs, to regulate transplant tourism and to regulate the source and rights of the organ donor. So in regulating quality the Ministry put out the interim provisions on clinical application for the management of human organ transplantation which addressed field strength, medical ethics, medical and surgical expertise as well as ICU care. In April of 2006 they formed the Committee on Organ Transplantation which developed clinical protocols to standardize practice. In November of 2006 they had a National Summit of Transplant Centers to announce these changes. This is the documents that came out and these are obviously the English translations actually we were provided these documents before the final English translation was approved but it really gave us a sense as to where and what they wanted to do. So the resulting changes in the practice of transplantation following these regulations was that it decreased the number of transplant centers from over 600 to approximately 150 and this was done by those criteria that were mentioned before so that they were done fairly inequitably and that over the time all 150 or so have been approved. During the process some advantages of working in a relatively authoritarian government is that they can decide that they don't want to accept or consider applications because they have enough and they don't need any more and that was indeed done in several cases. All provinces have at least one transplant center though. These are the specific regulations in regards to liver programs and I put this up only as an example. They were similar lists for other organ transplant programs and the point of putting these up there is that these are indeed criteria that would be similar in the U.S. and in fact are similar in the U.S. in order to have a CMS approved transplant program or even a third party approved transplant program. So volume, quality, outcomes, institutional support, etc. were all part of the requirements for any transplant program in China. Enforcement is always a problem as I was talking with Mr. McClain the other night who does a lot of work in China as well. A real problem is the lack of rule of law and that permeates all aspects of healthcare and certainly the practice of transplantation. And just because in China you develop a regulation, you have buy-in from the government, you have buy-in from many of the transplant centers but not all of the transplant centers doesn't mean that everyone accepts and goes by those regulations and in fact there have been episodes and I cite two here but there have been others that have been brought to the Ministry of Health's attention and once a thorough investigation has confirmed a transplant tourism case then the punishment is laid down and that is essentially to forbid that hospital to perform that type of transplant for a year once a identified case of transplant tourism is identified. So living donation has become an increasingly frequent component of a donor source in China especially as the number of prisoner organ donations has decreased because of regulations not only because of consenting as well but also because of the national review of capital cases in China the number of organ donations and I have no idea in reality about the number of executions but certainly the number of organs available for transplantation has decreased and although the Ministry of Health does not actively support the application of living donation feeling that the China's social structure is not well enough established and supportive enough to support the long-term healthcare issues of potential living donors even though they do not actively support it they have developed regulations surrounding living donor transplantation in order to try to make it as safe as possible for those patients. So from all of this work Jai Fu Hu is there looking much better than he did at that very hairy WHO conference and I and a fellow colleague Ili Mao have written a number of papers to document what the process is of how to improve the system of transplantation in China one of those areas is a transplant registry and you see in addition to me and Jai Fu there ST Fan who has been a long friend of mine he is based in Hong Kong he's chairman of Surgery Now in Hong Kong and was a visitor at UCLA when I was a fellow for a long period of time and he has developed the liver transplant registry for all of China and Haibo who is there here in the corner is really the hands-on guy for that project and has really helped keep the data flowing in good shape and this is the you can access this registry online the data you cannot access you have to have a user code and password so that's a level of transparency that we in the States have that China has not yet come to whereas in the U.S. anyone can go to the appropriate website and find out the survival statistics weight list numbers etc. of any transplant program in the U.S. China is not yet to that level of transparency but they clearly have a registry that is moving on and if you can see here there's the top quality programs in certain years that are right there that if you do have the access you can get those quality metrics within the system we have not been totally successful we had a meeting about brain death several years ago and it was not successful we recognized that it was a standard across the world in many countries not all countries and we from a medical point of view we were able to develop the appropriate criteria for China with the acceptable diagnostics that are available in most hospitals but was not able to get buy-in from the Ministry of Justice and so at the current time China still does not have a brain death law so this was just one of the transplant organ council meetings that I was invited to so to point out that there's outside review it's not just a bunch of Chinese people the other interesting aspect of that the bigger picture is you see some military people and this was the first meeting of the transplant organ transplant council that had the cooperation of the military in terms of trying to develop a national system so whereas Dr. Kaplan certainly mentioned that the military hospital system and the Ministry of Health hospital system are separate and not organized or administered under the same umbrella in transplantation we are starting and I'm not to say that it's totally integrated yet but at least they're starting to be the assumption that eventually they'll all be moved together so one of the questions that we had is we wanted to develop an organ donor system was how do we develop a voluntary citizen-based deceased organ donor pool when we don't have a brain death law which is the principle method of organ donors in the U.S. as we've heard about yesterday despite the issues that may be about declaration of death in either brain death or in DCDs so this is kind of showing a VIN diagram of how we view organ donors in the U.S. and mostly throughout the rest of the world you have the blue circle of brain death and you have the pink circle of donation after circulatory or cardiac death and those contribute to a total deceased donor pool what we did was rethink this paradigm and redefined deceased organ donation for China and what we saw was that we could incorporate the brain death donor into the DCD donor not declaring them brain dead but allowing them to proceed down a DCD donor pathway clinical algorithm so that they would their life support measures would be eliminated just as any DCD donor they would obviously die quicker whereas the standard DCD donor has perhaps some level of respiratory drive and some blood pressure responsiveness the brain dead donor does not and so once they go down the pathway they will actually presumably die quicker than the standard DCD and we're able to get usable organs from the whole group of potential donors rather than just throwing up our hands and saying that we failed and so we've defined what this pilot program of donors in China would be and we published that in Lancet and then we had that demonstration project going from April of 11 to January of 12 it essentially developed 26 OPOs that really didn't exist before from that period of time there were 292 organs that were transplanted in 31 different hospitals and 50% of those organs were procured in the last six months of the project now the number of organs from this system is now up to 546 from 207 donors and transplanted from those donors from 16 different regions the next aspect of this donor system that we're trying to develop is that of allocation so we looked around the world at allocation policies and developed a Chinese specific system and this is how the Chinese log on to this system and then identify the potential these were the transparency and equity and then if you look on that this is actually a screenshot of the donor of the potential candidates for a specific organ just as we would see in the US and the allocation goes from top down just like it does in the US when I was at the meeting that announced the results of the pilot project there was a very moving presentation by the father of a donor and I had always assumed that the organ donor system would really be driven by the younger people and the bigger cities who understood the importance of organ donation and the gift of life and gift of organs but in fact this is the story of a man a migrant farm worker whose son was in all likelihood brain dead from a traumatic injury and he agreed to allow his son's organs to be procured and transplanted and if there's any question about whether that feeling is of gifting and of donation is culture specific it is not this man had every one of the emotions that every one of us would have if our son or daughter had died and we were able to provide a gift of life to someone else and even though I don't speak Chinese after many of the trips that I've gone I knew every word he was saying and I felt every emotion that he was able to transmit and it was a very moving part of that whole meeting that really shows that it can work in China so what have we seen already in the last six years or so from the social aspect in 2005 and before it was really when I talked with transplant professionals they felt there was nothing wrong with executing prisoners and using them as donors the transplant tourism was good for the system and the Chinese will never embrace living donor transplantation in 2012 we've seen dramatic changes in those things and they are listed there so these are some of the things that we have done in the last six years I think the most important in that is is we've improved quality we've addressed many of the ethical issues we don't have 100% penetrance of this but we are making good strides what are our goals for the next five years making a voluntary deceased donor system robust enough to allow elimination of prisoners as organ donors to improve enforcement of regulations and to have onsite audits of transplant activity so that the enforcement is even easier to get to so once again thank you very much for the opportunity