Scientific Contributions

Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.
11-26, July 2006
Scientific Contribution
From Pigs to Humans: Xenotransplantation and a New Challenge to Medical Ethics

Shogo ASAMI
(Faculty of Foreign Studies, Sophia University, E-mail: shogo-a@sophia.ac.jp ) Abstract: Xenotransplantation is gaining attention as one option for organ
transplantation. It is hard to deny that there are some advantages to xenotransplantation. It seems clear, however, that there are more disadvantages than advantages. This paper discusses several reasons for not going ahead with xenotransplantation. It also suggests that we need to build a new ethics in the field of xenotransplantation. First I will briefly explain why xenotransplantation is treated as a hot topic and what kind of advantages and possibilities there are if we decide to adopt this new technology. I will further discuss and argue that despite the numerous merits xenotransplantation could bring, we should be very careful to treat it as only one among other options, and that we need to search for a new perspective on the medical ethics of transplantation. Keywords: Xenotransplantation, Infectious diseases, Animal Right, Identity, Utilitarianism, Autonomy
1. What is xenotransplantation Organ transplantation is gaining increasing attention. With significant advances in the technology, people have started to anticipate it to be the ultimate approach to therapy. However, there have been various limitations to organ transplantation so far, and the number of recipients who can actually receive organs has been quite limited. The situation has changed considerably since xenotransplantation appeared on the scene. Further, this new technology may change many aspects of organ transplantation dramatically.
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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.11-26, July 2006
Xenotransplantation is organ transplantation between species. Results of earlier operations indicate that the closer donors and recipients are, the higher the possibility of success. The more hereditarily distant the donor and recipients are, the more recipients are exposed to the risk of rejection. Because of this higher risk, trials of xenotransplantation have been limited. However, recently there are more trials of this procedure. Xenotransplantation now presents broader new possibilities as a result of new technology to prevent rejection. 2. The possibilities of xenotransplantation Xenotransplantation is gaining attention globally and Japan is no exception. Some experimental operations have been attempted and ethical committees in some universities are trying to form policies regarding xenotransplantation1. Why, then, is xenotransplantation becoming such a big issue? It is because xenotransplantaion offers solutions to many unsolved problems. At the same time, it also addresses ethical matters. The first problem it might solve is the shortage of donors and organs. In the U.S. the numbers of organs demanded by 1999 came to about 72,0002 while organs offered numbered only 20,0003. The number of people on waiting lists differ depending on the kind of organ. However, there is no denying that organs are in short supply. Therefore, we need a drastic solution to this problem, otherwise the number of people on waiting lists will increase year after year. Of course, there are people suffering outside the U.S, and these people are dying because of a shortage of organs. However, if animals could become donors (here I call them donors, though they do not offer their organs voluntarily), the situation would change dramatically. Rare animals couldnt become donors, of course, but the strongest donor candidates we have now are pigs. Pigs are abundant, and easily produced. If xenotransplantation by pigs was realized and organs to be
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transplanted were in short supply, there would be a drastic reduction in suffering for people on waiting lists. Also, there would be less ethical conflict regarding transplantation. We would not worry if the donors were deceased or supposedly deceased human beings. One well-known dilemma is the distribution of organs. There is an extreme theory entitled Survival Lottery, suggested by J. Harris4 which suggests that all members of the human race should be registered. Then, for example, if someone notices that As liver matches B and As lungs match C, A should give up his life for the survival of the other two members of the human race. Harris suggests that this would be more beneficial to society. Of course, there is a fierce discussion over this extreme theory. Is it reasonable? Does it have such a beneficial effect to justify the victims demise? How should we regard one mans right to sustain life? And the most important question is it ethical at all? This is quite a controversial theory and would offend many people. Here again, xenotransplantation could offer a solution and put an end to such controversial theories. Additionally, xenotransplantation will solve problems concerning the choice of recipients. For example, Mr. A may have a 70% chance of survival without transplantation while, with an organ-transplant, his chances of survival would increase to 90%. In the case of Mr. B, the chances of survival are 20% without a transplantation, while it will increase to as high as 40% with a transplantation. Which should we choose as the recipient, Mr. A or Mr. B? If we emphasize the medical benefit, we should choose Mr. A to receive a transplant. However, when we note the necessity, Mr. B would be the more promising candidate. This controversy regarding ethics arises only because organs are in short supply. If there were sufficient organs to distribute to all the people in need, there would not be this kind of difficulty. Furthermore, if organs of animals were available we would not have to worry whether we should or should not acquire organs from babies or small children. Organ transplantations from anencephalic infants, which are especially controversial, will no longer be a problem. Also, we
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wouldnt have to worry about illicit organ brokers, who are buying organs from healthy people in developing countries, problems which arise because organs are in short supply. Xenotransplantation seems to solve many of the ethical and practical problems we are now facing. Organ transplantation will not only save precious lives which would have been lost otherwise but also help to promote the quality of life of people who are now forced to a life of suffering. For example, people with serious kidney disease will be free from dialysis treatment if there are sufficient kidneys to be transplanted. You can see that xenotransplantation may be a key to open many doors that are now closed. Xenotransplantation is not limited to organs. Cells of animals could also be transplanted. Islets of Langerhans of pigs, which excrete insulin, have been transplanted to diabetic patients experimentally. Hepatic cells of pigs are used to attempt to cure hepatic failure in humans, and cells of blood coagulation factors are used to cure hemophilia. Cells to promote the growth of nerves are used to cure Parkinsons disease and Alzheimers disease, and animal cells are regarded as promising tools in treating chronic pain or Lou Gehrigs disease5. As I have noted, xenotransplantation is gaining more attention. You can see that there are several reasons why it will solve many medical and ethical problems. 3. The problems of xenotransplantation However, I believe xenotransplantation is not free from controversy. I would like to point out doubts surrounding xenotransplantation on three different levels and in three categories. The first problems that come to mind are social problems. The most serious is the problem of infectious diseases. Of course, there are other social problems, such as the legal, insurance or economic matters concerning xenotransplantation, but the most immediate concern is that of infectious diseases. The second problem is that of donors: Animal welfare and animal
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rights issues have to be addressed. The third problem is quite subjective. That is, the identity of recipients. When it comes to identity or spirituality, human beings will have more at stake than animals. These three levels/categories of problems are related to each other, but here I will divide them into three aspects to discuss them further. 3-A: Social problems regarding xenotransplantation The biggest social problem is that of infectious diseases. Scientists against xenotransplantation often emphasize the high risk of infectious diseases. It is no wonder that we are threatened by infectious diseases when we acquire organs from animals other than the human race. Xenotransplantation has been technologically difficult because of the rejection by our bodies when they encounter something unknown. To prevent this, we need to suppress our immune system by injecting strong immunosuppressants. But this renders the recipient vulnerable to strange viruses which might cause serious damage, not only to the body but also to society as a whole. In 1995, an American AIDS patient, Jeff Getty, planned to have an operation to receive transplanted bone-marrow from a baboon. Baboons have resistance to the HIV virus and they assumed that, by transplanting its bone-marrow, Mr. Getty would be able to produce lymph cells to resist the HIV virus. However, the Federal Drug Administration (FDA) stopped the operation. They claimed that there was a danger that the baboons cells might produce unknown viruses in the human body. Baboons have infections of their own. For example, they have retroviruses, so transplanting its cells to the human body might lead to totally unknown infectious diseases. I do not think we can ignore this possibility. For example, the introduction of the AIDS virus is not the only example. Many cases of amphixenosis have been reported. Most of the infectious diseases over the past decades (new variant Creutzfeldt-Jakob disease, Ebola
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Hemorrhagic Fever) were carried by animals. Therefore, hesitation to transplanting animals cells and organs are thus well justified. If an unknown infectious disease occurs, the recipient is not the only one who may be affected. The operating technicians might be affected and, ultimately, all of mankind will be exposed to the risk of infection, possibly resulting in worldwide panic. When we remember how AIDS jolted the world, we cannot treat the prospect lightly. There is no way of knowing how to treat an unknown disease. With todays increased mobility of humans on the globe, a disease in a small community on the African continent could be spread to the American continent the next day. There might be a stronger virus than the AIDS virus and, if that infection were air-borne, the result would be a disaster beyond imagination. Of course, supporters of xenotransplantation take into account all of these risks and consider how to avoid disaster. The adoption of pigs, and not monkeys, is one of the means of reducing these worries6. Monkeys are more likely to have amphixenosis and it seems that it is easier to take precautionary measures against pigs. But unknown viruses come from unknown sources, and how much damage certain viruses or bacteria may cause to mankind is not easy to grasp. The viruses of some influenza do not harm the animals that carry the virus but once the virus is introduced into humans it might affect the human body. Influenza will likely not be the only such virus. There might well be other viruses which do not harm animals but harm humans. Supporters of xenotransplantation are trying to avoid infection by adopting specific pathogen free pigs (pigs specifically produced for transplantation and isolated from some bacteria which might cause disease), but this does not exterminate all the risks of infection. An unknown virus and bacteria might be left untouched. Besides, there is always the risk of endogenous retrovirus. Though it might be dormant in the body of a natural host, xenotransplantation has the possibility of awakening or reactivating it and causing a brand new disease to arise. There is another danger. Human carriers of this unknown virus
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might not be aware of the virus during its incubation period. If such a period is relatively long, he would not notice that he is spreading the disease to other people. Here again, AIDS is an example. People could spread viruses before they notice that they have any virus at all. If the virus is strong but has a very long incubation period it will bring about a disaster and there may be few counter-measures. Of course, there are more problems than infection concerning xenotransplantation. Who should regulate xenotransplantation globally? Who should supervise public hygiene? How should the privacy of the transplanted people be protected? But even after raising these questions, we cannot deny that infection is the biggest problem. We should not go ahead with xenotransplantation for the moment, if we take into consideration the problems mentioned already. At the very least, we should be very careful in the implementation of xenotransplantation. At least when we perform a utilitarian calculation, the risk of infectious diseases is too high to realize xenotransplantation. There are advantages in doing it but, at the same time, we cannot deny the fact that people around the world will be threatened. It is not appropriate to leave the decision to the recipient alone, to allow him the right of self-determination. He might feel all right to go ahead with a dangerous operation and that he is willing to accept the result, whatever it is, but the entire world might be subjected to danger from this sole operation. It might exterminate society; it might exterminate mankind on earth. 3-B: Problems of donors When it comes to xenotransplantation, the donors are animals. Therefore, the problems of donors in xenotransplantation concerns animal welfare, animal rights and how animals are treated. Movements against animal abuse and animal experimentation are active in western countries7. In Great Britain, there are laws like the Prevention of Cruelty to Animals Act, the Protection of Animals Act and the Animals (Scientific Procedures) Act. ICLAS has documented
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guidelines for animal experiments and CIMOS have announced international principles for biomedical research which uses animals as experimental subjects. In these laws, replacement, reduction and refinement are emphasized. This means that, when biological or medical experiments are practiced, one should replace higher forms of life with lower levels of animals. Also, one should reduce the numbers of animals involved as much as possible. Besides, one should refine the methods so that the animals pain is minimized. Thinkers like Peter Singer have joined in the animal emancipation movement and advocated animal rights. They have tried to change the current situation where animals are abused and killed because people want to get food, want to hunt for fun and experiment to promote human quality of life8. They claim that what these people are practicing is speciesism. People ignore other animals benefit and pursue the benefit of humans solely. This kind of idea naturally affects the cause of xenotransplantation. When practicing xenotransplantation one has to kill animals to save humans. In some cases animals do not have to be killed, but they would suffer when people try to take cells or organs out of them. There is no denying that humans are taking into account their own well-being mainly and do not consider animals welfare. If the anti-speciesism movement becomes more widely active, it will not be easy to practice xenotransplantation. What kind of ethical standpoint should one take when accepting the concept of animal rights? It is to apply the spirit of utilitarianism (to reduce pain to the minimum and to enhance joy as much as possible) to animals. However, some people try to apply utilitarianism to those animals that do not seem to feel pain or joy. At this point, environmental ethics become more important than utilitarianism. Environmental ethics conflict with modern classical liberalism. What environmental ethics regard as important is the well-being of the globe and its inhabitants as a whole and does not pursue only ones own well-being or that of mankind9.
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The concept of autonomy of person and utilitarian calculation are both modern ideas which have been leading ethics of our time. However, it is difficult to choose only one of them. We usually reach a compromise between the two standpoints. Especially in the case of bioethics and medical ethics, which are closely related to our lives, we do need a compromise. What if we stick to Kants autonomy? Kant claims we should do what we should even though the world perishes. Kant claims we should not lie whatever happens. It is not wise to stick to this standpoint in a medical scene. It does not give answers to the questions of whether we should truthfully notify cancer or AIDS patients of their conditions. We cannot accept the concept of the Survival Lottery, which is extremely utilitarian. Fierce controversies occur and it shows that it is not acceptable to many of us. Modern ethics have reached compromises between these two extreme standpoints, however, the concept of animal rights does not stay in the frame of modern ethics. It contradicts xenotransplantation from outside the medical scene. We should take into account this new standpoint when we discuss the rights and wrongs of xenotransplantation. Of course, some people are against animal rights. They say we should pay attention to animal welfare, but if human beings get something out of it, animals should give up their lives. We should try to give as little pain as possible when we experiment with animals, but we can take out their organs and kill them freely if it contributes to some members of mankind. But the necessity of consideration for animals has been agreed by many, and is in the process of being written in law. Of course, there are many points to be discussed. Should we be content with the concept of animal or should we give animals claims to animal rights? How should we balance animal welfare and human well-being? Can we really distinguish animal welfare from animal rights? People take different standpoints. Nonetheless, taking into account the well-being of animals in xenotransplantation is in the mainstream. Modern utilitarianism and individual autonomy do not give answers to the rights or wrongs of xenotransplantation. Thus, xenotransplantation demands new ethics rather than utilitarianism and individual
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autonomy. The next topic, the problem of the identity of the recipients, also cannot be answered by present ethics. 3-C: Subjective level There is no doubt that transplantation jolts the recipients identity. Even in the case of allogeneic transplantation, an identity problem arises. Am I still Me with another persons organ? If the transplanted organ is a heart, the problem would be more acute. If one is transplanted with another persons brain, we have to ask seriously if the person is what he used to be. Xenotransplantation raises another question. Even an atheist or non-religious person cannot help feeling doubt for his/her identity when he/she is kept alive because an animals organ is planted into his/her body. The Nuffield Council on Bioethics points out this identity problem10. An important question is how xenotransplantation might affect individual recipients. A persons self-image is clearly related to their perception of the body. When assessing the impact of xenotransplantation it will be necessary to consider how a persons perception of their body, and of their identity or self-image, is affected Virtually nothing is known about the effects of xenotransplantation upon perceptions of identity. Receiving an animal transplant might cause different stresses. The response is likely to reflect notions of what it is to be a person, to be human and to be an animal. There is no doubt that xenotransplantation jolts human identity. We have to consider the problem of identity in practicing xenotransplantation. In the course of xenotransplantation, we have to humanize pigs, and pignize humans. We will introduce human genes into pigs, pig genes into humans. The identity of the human race will be drastically shaken. Why do we have to take such extreme measures? It is to prevent the rejection the recipient might show. Soon after the operation, the recipients are exposed to the risk of hyperacute type of rejection. Then they will be in danger of acute rejection and even after a few months
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they are still at the risk of chronic rejection. To overcome hyperacute type of rejection, we have to humanize pigs and pignize humans. You may think that we do not have to take such extreme measures. We can simply use immunosuppressants, cant we? But normal immunosuppressants like Cyclosporine and FK506 will not prevent acute rejection resulting from xenotransplantation, especially when the operation is practiced between distant species like humans and pigs. Some people claim that we should adopt chimpanzees and monkeys as donors to prevent rejection, as they are much more akin to humans than pigs. Other people, however, are strongly against it. There is a serious doubt that animal welfare might be in danger if we use species close to the human race as organ donors. Besides, there not being enough monkeys, the biggest problem remains the risk of infection from disease. Here again, we have to remember that AIDS was transferred to humans from monkeys. Even though some viruses do no harm to monkeys, they may be fatal to humans. That is why pigs are promising candidates as donors of organs. They are easy to breed, relatively free from microorganism contamination and easier to control against infection11. Pigs have been livestock for a long time for the human race and very few disputes will arise concerning animal welfare when we use pigs for our purpose. Pigs are about the size of humans and the body structures are similar. Our kidneys and digestive systems are alike, as are the length of coronary and density of urine. That is why they are regarded as one of the most promising donor candidates. However, as we have noted, a hyperacute type of rejection is believed to occur when we adopt pigs as donors. We must find some ways to overcome this response. Recently, it has become clear what elements in pigs enhance hyperacute types of rejection. Antibodies which cause immune reaction and alexin, one of the components of blood, play important roles here. Natural antibodies which resist alpha-galactose antigen are fatal. Alpha-galactose antigen is a sugar molecule seen on the surface of pigs cells, and most mammals have this antigen. However, humans and monkeys are an exception. That is why the human body produces natural antibodies against alpha-galactose
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antigen. On the other hand, alexin exists in blood serum and assists immune reaction. These two factors combine and cause a hyperacute reaction. How can we prevent hyperacute rejection? People have explored and considered the possibilities in several ways12. The first idea is that we could remove alpha-galactose antigen from pigs. We could artificially destroy the galactosyltransferase that produces alpha-galactose antigen. That is, producing Knock-out animals (animals in which some genes have been destroyed), namely Knock-out pigs. American and Korean research groups have succeeded in producing such pigs13, but the success is only partial. They destroyed genes which produce alpha-galactose antigen, but destruction is limited in one of the paired genes. There is very little hope for practical application of the technology so far. The second idea is to remove alexin, but it is also difficult to put into practice. The third idea seems more practical and many researchers are pursuing this. That is to stop the immune reaction by restraining the action of alexin, even when the natural human antibodies contact with the pigs organs. This is essentially to produce pigs with human complemented regulatory protein, which controls the activity of alexin. There are various ways to realize this, all of which do the same thing in the end. To introduce human genes into pigs artificially, by injecting pigs with genes that they were not born with, we will have transgenic pigs, a derivation of transgenic animal. That is, the humanization of pigs. The fourth idea is to produce a chimerical situation, by producing an immune system in which the donors system and the recipients system works in unison. It is supposed to be possible to make up such a system by injecting pigs bone-marrow and genes into humans. That is the pignization of humans. If we pursue this theory further, it might be suggested that pigs genes should be injected into every human fetus, so that the fetus will grow with immune intolerance. After all, no one knows who will need transplantation one day. How should we regard this humanization of pigs and pignization of
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humans? It is not acceptable to anyone, I believe. People who regard humans as supreme and superior to animals will take it as an impairment of human dignity, while people who regard animals as equal beings will take it as an impairment of animal dignity. The identity of the human race will be threatened and the identity of an individual will be threatened too. Biologically speaking, an immune system is what divides oneself from others. An immune system makes a person who he/she is. Pignization of humans will change the person drastically. Of course, people are subject to permanent changes. Daily experiences change people and a person might change from morning to evening yet these kinds of changes are gradual. While getting transplanted with another animals organ is drastic and urgent, the amount of transition is much larger. If every human fetus was injected with pigs genes, the whole identity of the human race will be in danger. However little the change of an immune system is, this might lead to a big alteration in the human race. At least, no one knows how drastic the change would be. Actually, no one knows how to calculate the risk and we do not know if we will be able to calculate it as it will be very difficult, to say the least. To deal with the problem of xenotransplantation, we need to build unprecedented medical ethics. Our current ethics based on self-determination will not offer answers to the question of xenotransplantation. We need intergenerational ethics, and those ethics should cover the possibilities of our transforming to beings other than what we are today. 4. New challenge to medical ethics I have discussed xenotransplantation on three different levels14. Of course, there are other problems too. However, we could reach some conclusions from these three categories. First of all, we should be very careful in practicing xenotransplantation. There are, of course, many good points to the practice of xenotransplantation, but there are controversial points, too. The problems are not only numerous, but very serious. They might jolt
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the concepts of humanity and society fundamentally. We cannot give a definite yes to xenotransplantation yet. Of course, with advances in medical technology, the situation might change and we will need to re-consider. But, we should at least be very cautious at the moment. We need to consider the problems surrounding xenotransplantation now. If medical technology advances further and artificial organs become available, or if regenerative medicine is developed to the point that there will be no need for transplantation, we do not have to ask the question anymore. But, compared to organs such as hearts, there is relatively little hope to realize artificial livers etc. Organs like the heart have relatively simple mechanics and are easier to produce artificially, but organs with complex biochemical reactions are much more difficult to create. Cloning and regenerative medicines have the potential to solve many medical problems but here again there will be a dispute concerning ethics. Xenotransplantation is the strongest option, if we take into account the shortage of organs at the moment 15 . Therefore, we should discuss the ethics of xenotransplantation now. In addition, the concept of xenotransplantation raises the necessity of new ethics. We must admit that utilitarianism is useful in some ways and individual autonomy and self-determination are effective in some situations. However, these do not answer the questions raised by xenotransplantation. We need to reach a new standpoint where utilitarianism and individual autonomy are sublated. We need to search for new theories through new attempts. It will be a long and winding road, but medical ethics is not the only region where autonomy and utilitarianism should be sublated. For example, there is an attempt to combine medical ethics, especially those based on individual autonomy, with environmental ethics. There is also an attempt to combine ethics of virtue with utilitarianism and autonomy16. Ethics of virtue go back as far as the time of Aristotle and is concerned with life and the way of living in general. It is different from general ethics which aim at establishing universal moral standards.
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Some people consider Care Ethics as one of the ethics of virtue and claim the necessity of that17. Others try to combine Care Ethics with the modern doctrine of individual autonomy. What Axel Honneth is trying to do is a good example. He is trying to combine Habermas argumentation (a modern ethic) with the ethics of one-way dedication, a post-modern ethic that is basically a form of Care Ethics18. We could search for the new direction by referring to these new attempts in ethics in general. Even when it seems remote from medical ethics, we should consider the possibility, as sublation between autonomy and utilitarianism is not easy to accomplish. Notes
Kyushu University etc. Ministry of Health and Welfare also admonished on xenotransplantation. Refer to the articles in the Yomiuri Shimbun (Sep.23, 2000) and the Mainichi Shimbun (May 21, 2001). In spite of a recent increase in interest in xenotransplantation, there are few books readable in Japanese on this topic. I can recommend one of the few: Kazuya Yamanouchi, Ishuishoku, Kawadeshobo-Shinsha 1999. 2 According to data provided by UNOS (United Network for Organ Sharing). The newest data can be seen on http://www.unos.org. 3 According to the data provided by UNOS (United Network for Organ Sharing) 4 John Harris, Survival Lottery, Philosophy, 50, 1975, 81-87. 5 Cf. David K.C.Cooper, Robert P.Lanza, XENO: The Promise of Transplanting Animal Organs into Humans, Oxford UP, 2000, Chap.9. 6 There are other reasons too. I will refer to them later in this paper. 7 Refer to the book by Yamaouchi mentioned in 1 on brief history and current situation on this topic. 8 Refer to Peter Singer ed. In Defence of Animals, Blackwell, 1985. 9 It is interesting that Peter Singer is a utilitarian. However, ecologists in general dont regard themselves as utilitarians. It is difficult to do a utilitarian calculation in environmental ethics. There are too many variables and people have different views as to what they consider joy or merit. 10 The Nuffield Council on etBiohics, Animal-to Human Transplants: the ethics of xenotransplantation, 1996, chap.9) http://www.nuffieldbioethics.org. 11 Baboons are sometimes regarded as promising donor candidates, but they are not sufficient in numbers and are known to have many viruses that are dangerous to humans. 12 The second and third way mentioned here are mainly from the book by Yamanouchi mentioned in 1. See page 89. 13 See the article in Asahi Shimbun on January 4, 2001. 14 As I have noted, there is no way to divide the three categories clearly. Problems
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of each category are related closely. 15 The Nuffield Council on Bioethics also reports that xenotransplantation is one of the most promising ways to make up for the shortage of available organs. Refer to 10. 16 Martha Nussbaum holds this standpoint. (The Examined Life: Episode 121, Is Ethics based on Virtue? A video educational program from Telecourses). 17 Reference to Marilyn Friedman is mentioned in the video program in 16. 18 Refer to Das Andere der Gerechtigkeit by Axel Honneth (Suhrkamp, 2000) ; Politiques de lamiti by Jacques Derrida (Galile, 1884).
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Journal of Philosophy and Ethics in Health Care and Medicine, No.1, pp.

11-26, July 2006

From Pigs to Humans: Xenotransplantation and a New Challenge to Medical Ethics

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